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Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

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ClinicalTrials.gov Identifier: NCT02029521
Recruitment Status : Completed
First Posted : January 8, 2014
Results First Posted : August 21, 2014
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Clark Bishop, Brigham Young University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Interventions Dietary Supplement: Oral reduced l-glutathione
Dietary Supplement: Placebo
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Period Title: Overall Study
Started 24 23
Completed 22 22
Not Completed 2 1
Reason Not Completed
Protocol Violation             1             0
Withdrawal by Subject             1             1
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate Total
Hide Arm/Group Description The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
Pediatric cystic fibrosis patients, ages 15 months to 10 years
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
15 months to 3 years 6 6 12
3 years to 10 years 16 16 32
[1]
Measure Description: 15 months to 3 years and greater than 3 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
14
  63.6%
10
  45.5%
24
  54.5%
Male
8
  36.4%
12
  54.5%
20
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 22 participants 22 participants 44 participants
22 22 44
Body Mass Index Percentile   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentile adjusted for age and sex
Number Analyzed 22 participants 22 participants 44 participants
25.1  (15.9) 31.1  (14.1) 28.3  (15.1)
[1]
Measure Description: Body Mass Index for patients with standardized percentile
Weight Percentile  
Mean (Standard Deviation)
Unit of measure:  Percentile adjusted for sex and age
Number Analyzed 22 participants 22 participants 44 participants
24.2  (13.7) 33.5  (13.4) 26.9  (13.6)
Height Percentile  
Mean (Standard Deviation)
Unit of measure:  Percentile adjusted for weight and heigh
Number Analyzed 22 participants 22 participants 44 participants
36.3  (14.4) 39.3  (13.5) 37.7  (13.9)
Fecal Calprotectin  
Mean (Standard Deviation)
Unit of measure:  Micrograms/gram feces
Number Analyzed 22 participants 22 participants 44 participants
113.2  (52.5) 76.1  (32.2) 94.6  (47)
Forced Expiratory Volume at one second.   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 22 participants 22 participants 44 participants
63.5  (4.8) 71  (7.8) 66.9  (7.3)
[1]
Measure Description: Forced Expiratory Volume at one second. Percentile normalized by age, height and gender.
Forced Vital Capacity   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent Predicted
Number Analyzed 22 participants 22 participants 44 participants
81.8  (8.7) 88.2  (9.6) 84.7  (9.4)
[1]
Measure Description: Forced Vital Capacity percentile normalized by age, height and gender
Gene Mutations  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
G551D/1303K 1 0 1
DelF508/R117H 1 0 1
R117H/G542X 1 2 3
DelF508/DelF508 4 5 9
DelF508/R553X 2 0 2
W1282X/R347P 1 0 1
DelF508/N1303K 1 1 2
DelF508/3849+10KBCT 1 1 2
G551D/621+1GT 1 0 1
W1282X/DelF508 2 1 3
R117H/R347P 1 1 2
R117H/W1282X 1 0 1
DelF508/G542X 1 2 3
3849+10kb/N1303k 1 0 1
N1303K/R553X 1 0 1
G551D/DelF508 1 2 3
R117H/1466delAATT 1 0 1
DelF508/G576X 0 1 1
DelF508/S489X 0 1 1
G542X/G542X 0 1 1
DelF508/R347P 0 1 1
R117H/R117H 0 1 1
N1303k/G542X 0 2 2
Sweat Chloride Test  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 22 participants 22 participants 44 participants
87.7  (15.8) 85.0  (15.6) 86.3  (15.6)
Participants' Lipase Intake in Units Per Day  
Mean (Standard Deviation)
Unit of measure:  Units of lipase
Number Analyzed 22 participants 22 participants 44 participants
130909.1  (54590.2) 123181.8  (47044.7) 127045.5  (50512.7)
Bacteriology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
A. xylososidans 3 1 4
MRSA 0 1 1
PA 2 3 5
Staph 7 9 16
Normal flora 3 2 5
PA and S. maltophilia 1 0 1
PA and Staph 5 6 11
Staph and A. xylososidans 1 0 1
White Blood Cell Count   [1] 
Mean (Standard Deviation)
Unit of measure:  1000 cells/mm^3
Number Analyzed 22 participants 22 participants 44 participants
9.1  (2.0) 8.9  (2.7) 9.0  (2.4)
[1]
Measure Description: Total White Blood Cell Count. 1000 per cubic millimeter
ALT   [1] 
Mean (Standard Deviation)
Unit of measure:  Units per liter
Number Analyzed 22 participants 22 participants 44 participants
23.2  (9.3) 22.6  (11.4) 22.9  (10.3)
[1]
Measure Description: peripheral blood Alanine AminoTransferase
Vitamin E   [1] 
Mean (Standard Deviation)
Unit of measure:  Micrograms per ml.
Number Analyzed 22 participants 22 participants 44 participants
7.7  (1.6) 7.5  (1.6) 7.6  (1.6)
[1]
Measure Description: Peripheral blood vitamin E, micrograms per ml.
C-Reactive Protein   [1] 
Mean (Standard Deviation)
Unit of measure:  Miligrams per liter
Number Analyzed 22 participants 22 participants 44 participants
13.3  (7.7) 12.1  (6.6) 12.7  (7.1)
[1]
Measure Description: C-Reactive Protein in peripheral blood
Frequency of Abdominal Pain   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 7 11 18
2- rare 10 4 14
3- frequently 4 6 10
4- constantly 1 1 2
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Abdominal Pain   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 6 11 17
2- light 12 4 16
3- moderate 3 7 10
4- serious 1 0 1
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Belching   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 14 15 29
2- rare 3 3 6
3- frequently 5 4 9
4- constantly 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Belching   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 14 3 17
2- light 5 10 15
3- moderate 3 8 11
4- serious 0 1 1
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Flatulence   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 3 4 7
2- rare 10 9 19
3- frequently 8 9 17
4- constantly 1 0 1
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Flatulence   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 3 4 7
2- light 11 10 21
3- moderate 8 8 16
4- serious 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Lack of Appetite   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 1 5 6
2- rare 10 13 23
3- frequently 8 4 12
4- constantly 3 0 3
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Lack of Appetite   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 1 5 6
2- light 11 13 24
3- moderate 7 4 11
4- serious 3 0 3
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Bloating   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 2 4 6
2- rare 7 7 14
3- frequently 12 10 22
4- constantly 1 1 2
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Bloating   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 2 4 6
2- light 7 7 14
3- moderate 13 10 23
4- serious 0 1 1
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Nausea   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 11 15 26
2- rare 8 7 15
3- frequently 3 0 3
4- constantly 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Nausea   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 11 15 26
2- light 9 6 15
3- moderate 2 1 3
4- serious 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Vomiting   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 16 18 34
2- rare 6 4 10
3- frequently 0 0 0
4- constantly 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Vomiting   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 16 18 34
2- light 6 4 10
3- moderate 0 0 0
4- serious 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Heart Burn   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 17 18 35
2- rare 1 2 3
3- frequently 4 2 6
4- constantly 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Heart Burn   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 17 18 35
2- light 1 1 2
3- moderate 4 3 7
4- serious 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Diarrhea   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 9 9 18
2- rare 9 11 20
3- frequently 4 2 6
4- constantly 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Diarrhea   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 9 10 19
2- light 10 10 20
3- moderate 3 2 5
4- serious 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of More than 2 Bowel Movements Per Day   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 4 10 14
2- rare 12 6 18
3- frequently 5 6 11
4- constantly 1 0 1
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of More Than 2 Bowel Movements Per Day   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 4 10 14
2- light 12 8 20
3- moderate 5 4 9
4- serious 1 0 1
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Less Than 2 Bowel Movements Per Week   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- never 18 17 35
2- rare 0 2 2
3- frequently 4 3 7
4- constantly 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Less Than 2 Bowel Movements Per Week   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
1- absent 18 17 35
2- light 0 3 3
3- moderate 4 2 6
4- serious 0 0 0
[1]
Measure Description: Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
1.Primary Outcome
Title Weight Percentile at 3 Months
Hide Description Weight Percentile at 3 months adjusted for sex and age
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Weight Percentile, sex and age adjusted
33.5  (14.9) 31.0  (13.4)
2.Primary Outcome
Title Height Percentile
Hide Description Height Percentile adjusted for sex and age
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Percentile adjusted for age and sex
39.3  (11.9) 38.0  (13.8)
3.Primary Outcome
Title BMI Percentile
Hide Description Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
BMI percentile not available for children under 2 years of age.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percentile adjusted for age and sex
37.1  (33.6) 47.5  (17.0)
4.Primary Outcome
Title BMI Percentile
Hide Description Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percentile adjusted for age and sex
47.5  (14.0) 36.0  (17.0)
5.Primary Outcome
Title Weight Percentile
Hide Description Weight percentile, adjusted for sex and age
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Percentile adjusted for age and sex
43.2  (12.3) 31.8  (14.0)
6.Primary Outcome
Title Height Percentile
Hide Description The subjects were measured over the course of the study to determine if treatment improved height percentile.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Percentile adjusted for age and sex
43.3  (12.5) 36.5  (13.2)
7.Primary Outcome
Title Fecal Calprotectin
Hide Description Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Micrograms/gram feces
61.2  (26.4) 76.6  (30.7)
8.Secondary Outcome
Title Forced Vital Capacity
Hide Description Forced vital capacity percent predicted
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Pulmonary function tests not performed on children under the age of 5
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: percent predicted
87.2  (7.2) 88.8  (10.3)
9.Secondary Outcome
Title FEV1
Hide Description Forced expiratory volume at one second, percent predicted
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Pulmonary function tests not performed on children under the age of 5
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: Percent predicted
73.2  (5.6) 73.0  (11.1)
10.Secondary Outcome
Title Bacteriology
Hide Description Expectorated sputum or throat swab
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
A. xylososidans 1 0
MRSA 0 0
PA 0 4
Staph 12 9
Normal flora 4 2
PA and S. maltophilia 0 0
PA and Staph 4 7
Staph and A. xylososidans 0 0
S. maltophilia 1 0
11.Secondary Outcome
Title Forced Vital Capacity
Hide Description Percent predicted of forced vital capacity.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
PFT's not done on children under age of 5.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: Percent Predicted
92.3  (7.3) 83.9  (8.2)
12.Secondary Outcome
Title FEV1
Hide Description Forced expiratory volume at one second, percent predicted.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
PFT's not done on children under age of 5.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: Percent predicted
81.5  (4.9) 71.6  (8.3)
13.Secondary Outcome
Title C-Reactive Protein (CRP)
Hide Description CRP was measured to determine if this test fell during the course of treatment.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: milligrams per liter
10.9  (5.6) 14.7  (6.5)
14.Secondary Outcome
Title White Blood Cell Count
Hide Description White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: 1000 cells/mm^3
8.4  (1.5) 9.5  (2.4)
15.Secondary Outcome
Title Vitamin E
Hide Description Serum Vitamin E levels were measured to determine if treatment affected this test.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: milligrams per liter
8.6  (1.6) 6.8  (1.4)
16.Secondary Outcome
Title Alanine Aminotransferase (ALT)
Hide Description ALT was measured to determine if liver function was affected by treatment over the course of the study.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description:

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: units per liter
18.1  (7.0) 25.8  (10.9)
17.Secondary Outcome
Title Bacteriology
Hide Description Expectorated sputum or throat swab
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
A. xylososidans 0 0
MRSA 0 1
PA 1 7
Staph 12 8
Noraml flora 6 0
PA and S. maltophilia 0 0
PA and Staph 1 5
Staph and A. xylososidans 0 0
S. maltophilia 1 1
Strep B 1 0
18.Secondary Outcome
Title Frequency of Abdominal Pain
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 15 9
2- rare 6 7
3- frequently 1 6
4- constantly 0 0
Did Not Answer 0 0
19.Secondary Outcome
Title Severity of Abdominal Pain
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 14 9
2- light 7 9
3- moderate 0 3
4- serious 0 0
Did Not Answer 1 1
20.Secondary Outcome
Title Frequency of Belching
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 18 11
2- rare 4 6
3- frequently 0 5
4- constantly 0 0
Did Not Answer 0 0
21.Secondary Outcome
Title Severity of Belching
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 18 11
2- light 3 6
3- moderate 0 4
4- serious 0 0
Did Not Answer 1 1
22.Secondary Outcome
Title Frequency of Flatulence
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 7 3
2- rare 14 10
3- frequently 1 9
4- constantly 0 0
Did Not Answer 0 0
23.Secondary Outcome
Title Severity of Flatulence
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 7 3
2- light 13 11
3- moderate 1 7
4- serious 0 0
Did Not Answer 1 1
24.Secondary Outcome
Title Frequency of Lack of Appetite
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 11 4
2- rare 11 14
3- frequently 0 4
4- constantly 0 0
Did Not Answer 0 0
25.Secondary Outcome
Title Severity of Lack of Appetite
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 11 3
2- light 10 14
3- moderate 0 4
4- serious 0 0
Did Not Answer 1 1
26.Secondary Outcome
Title Frequency of Bloating
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 6 2
2- rare 14 9
3- frequently 2 10
4- constantly 0 1
Did Not Answer 0 0
27.Secondary Outcome
Title Severity of Bloating
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 6 2
2- light 14 11
3- moderate 1 7
4- serious 0 1
Did Not Answer 1 1
28.Secondary Outcome
Title Frequency of Nausea
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 14 14
2- rare 8 7
3- frequently 0 1
4- constantly 0 0
Did Not Answer 0 0
29.Secondary Outcome
Title Severity of Nausea
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 13 13
2- light 8 7
3- moderate 0 1
4- serious 0 0
Did Not Answer 1 1
30.Secondary Outcome
Title Frequency of Vomiting
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 21 15
2- rare 1 7
3- frequently 0 0
4- constantly 0 0
Did Not Answer 0 0
31.Secondary Outcome
Title Severity of Vomiting
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 20 14
2- light 1 7
3- moderate 0 0
4- serious 0 0
Did Not Answer 1 1
32.Secondary Outcome
Title Frequency of Heart Burn
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 17 18
2- rare 5 3
3- frequently 0 1
4- constantly 0 0
Did Not Answer 0 0
33.Secondary Outcome
Title Severity of Heart Burn
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 17 18
2- light 4 2
3- moderate 0 1
4- serious 0 0
Did Not Answer 1 1
34.Secondary Outcome
Title Frequency of Diarrhea
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 18 11
2- rare 4 8
3- frequently 0 3
4- constantly 0 0
Did Not Answer 0 0
35.Secondary Outcome
Title Severity of Diarrhea
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 17 10
2- light 4 8
3- moderate 0 3
4- serious 0 0
Did Not Answer 1 1
36.Secondary Outcome
Title Frequency of More Than 2 Bowel Movements Per Day
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 15 12
2- rare 6 3
3- frequently 1 7
4- constantly 0 0
Did Not Answer 0 0
37.Secondary Outcome
Title Severity of More Than 2 Bowel Movements Per Day
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 14 12
2- light 7 4
3- moderate 0 5
4- serious 0 0
Did Not Answer 1 1
38.Secondary Outcome
Title Frequency of Less Than 2 Bowel Movements Per Week
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- never 19 16
2- rare 3 5
3- frequently 0 1
4- constantly 0 0
Did Not Answer 0 0
39.Secondary Outcome
Title Severity of Less Than 2 Bowel Movements Per Week
Hide Description Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Reduced L-glutathione Placebo Oral Calcium Citrate
Hide Arm/Group Description:
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
1- absent 17 15
2- light 4 4
3- moderate 0 2
4- serious 0 0
Did Not Answer 1 1
Time Frame 6 months of the trial
Adverse Event Reporting Description Patients kept a daily journal. They reported change in symptoms such as bloating, abdominal pain, as well as anorexia and hunger.
 
Arm/Group Title Oral Reduced L-glutathione Placebo Calcium Citrate
Hide Arm/Group Description

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
All-Cause Mortality
Oral Reduced L-glutathione Placebo Calcium Citrate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Reduced L-glutathione Placebo Calcium Citrate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Reduced L-glutathione Placebo Calcium Citrate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
This trial was limited to one site. The number was relatively small. Since PFT's were not done on children under the age of 5, there is even smaller number of participants contributing PFT data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clark Bishop
Organization: Intermountain Healthcare
Phone: 385 224 7343
Responsible Party: Clark Bishop, Brigham Young University
ClinicalTrials.gov Identifier: NCT02029521     History of Changes
Other Study ID Numbers: FIMP/clin.stud/2010/1.
First Submitted: December 30, 2013
First Posted: January 8, 2014
Results First Submitted: June 20, 2014
Results First Posted: August 21, 2014
Last Update Posted: February 8, 2016