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Effect of Glycine in Cystic Fibrosis

This study has been terminated.
(Some of the researchers finished their participation in the study.)
Sponsor:
Collaborators:
Hospital Infantil de Mexico Federico Gomez
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Mario H. Vargas, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier:
NCT01417481
First received: August 15, 2011
Last updated: October 30, 2014
Last verified: October 2014
Results First Received: September 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Dietary Supplement: Glycine
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients attending the Hospital Infantil de México and the Instituto Mexicano del Seguro Social (both in Mexico city) were recruited from March 7, 2012 to October 31, 2012. The two arms of the study were: 1) Glycine, then placebo, and 2) Placebo, then glycine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Glycine, Then Placebo

First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).

Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).

Placebo, Then Glycine

First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).

Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).


Participant Flow for 3 periods

Period 1:   First Intervention (8 Weeks)
    Glycine, Then Placebo     Placebo, Then Glycine  
STARTED     8     7  
COMPLETED     8     5  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  

Period 2:   Washout (2 Weeks)
    Glycine, Then Placebo     Placebo, Then Glycine  
STARTED     8     5  
COMPLETED     8     5  
NOT COMPLETED     0     0  

Period 3:   Second Period (8 Weeks)
    Glycine, Then Placebo     Placebo, Then Glycine  
STARTED     8     5  
COMPLETED     8     5  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The total number of patiens was fewer than planned mainly because other protocols were running concurrently. The protocolo had to be concluded because some of the researchers finished their participation.

Reporting Groups
  Description
Glycine, Then Placebo

First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).

Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).

Placebo, Then Glycine

First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).

Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).

Total Total of all reporting groups

Baseline Measures
    Glycine, Then Placebo     Placebo, Then Glycine     Total  
Number of Participants  
[units: participants]
  8     7     15  
Age [1]
[units: participants]
     
<=18 years     6     7     13  
Between 18 and 65 years     2     0     2  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.39  ± 5.82     11.00  ± 4.01     12.81  ± 5.19  
Gender  
[units: participants]
     
Female     6     3     9  
Male     2     4     6  
Region of Enrollment  
[units: participants]
     
Mexico     8     7     15  
[1] During the course of the study, inclusion criteria was expanded to include subjects older than 15 years of age.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in Serum Concentration of Inflammatory Biomarkers (Other Than TNF-alpha)   [ Time Frame: 8 weeks ]

2.  Primary:   Changes in Sputum Concentration of Inflammatory Biomarkers (Other Than IL-6 and G-CSF)   [ Time Frame: 8 weeks ]

3.  Primary:   Changes in Serum Concentration of Inflammatory Biomarkers (TNF-alpha)   [ Time Frame: 8 weeks ]

4.  Primary:   Changes in Sputum Concentration of Inflammatory Biomarkers (IL-6)   [ Time Frame: 8 weeks ]

5.  Primary:   Changes in Sputum Concentration of Inflammatory Biomarkers (G-CSF)   [ Time Frame: 8 weeks ]

6.  Secondary:   Changes in Clinical Data Scores (Other Than Sputum Production, Dyspnea and Global Symptoms)   [ Time Frame: 8 weeks ]

7.  Secondary:   Changes in Score for Sputum Production, Dyspnea and Global Symptoms   [ Time Frame: 8 weeks ]

8.  Secondary:   Changes in Pulse Oximetry, FEV1/FVC, and FEF50.   [ Time Frame: 8 weeks ]

9.  Secondary:   Changes in FEV1, FEF25, and FEFmax   [ Time Frame: 8 weeks ]

10.  Secondary:   Changes in Other Spirometric Variables   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mario H. Vargas
Organization: Instituto Nacional de Enfermedades Respiratorias
phone: (+55)54871771
e-mail: mhvargasb@yahoo.com.mx


Publications:

Responsible Party: Mario H. Vargas, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT01417481     History of Changes
Other Study ID Numbers: Glycine in CF
Study First Received: August 15, 2011
Results First Received: September 9, 2014
Last Updated: October 30, 2014
Health Authority: Mexico: Ministry of Health