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Gulf War Illness: Evaluation of an Innovative Detoxification Program

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ClinicalTrials.gov Identifier: NCT01672710
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : December 28, 2018
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
United States Department of Defense
The Sage Colleges
Women's College Hospital
Severna Park Health and Wellness Center
Information provided by (Responsible Party):
David O. Carpenter, University at Albany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gulf War Illness
Intervention Drug: plain crystalline niacin, exercise, sauna
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Niacin, Exercise, Sauna, no Intervention
Hide Arm/Group Description plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol. waitlisted group receives treatment as usual for 4 weeks
Period Title: Controlled Comparison 5 Week Follow-up
Started 22 10
Completed 22 [1] 10 [2]
Not Completed 0 0
[1]
sauna intervention group repeat all assessments 7 days after complete the regimen
[2]
waitlist group repeat baseline assessments after 4 week time period then begin sauna
Period Title: Waitlist Assessed After Sauna Regimen
Started 22 [1] 10 [2]
Completed 22 [3] 9
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
[1]
immediate start group no further assessments until 3 month follow up
[2]
waitlisted group receive the 4 week intervention and complete 7 day assessments
[3]
non applicable, cannot compare the immediate start and waitlist in this period
Period Title: 3 Month Follow up
Started 22 9
Completed 16 5
Not Completed 6 4
Reason Not Completed
Lost to Follow-up             2             3
follow up due after termination date             4             1
Arm/Group Title Niacin, Exercise, Sauna, no Intervention Total
Hide Arm/Group Description plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol. treatment as usual for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 22 10 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 10 participants 32 participants
51.7  (7.9) 50.2  (5.5) 51.2  (7.2)
[1]
Measure Description: in years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 10 participants 32 participants
Female
7
  31.8%
3
  30.0%
10
  31.3%
Male
15
  68.2%
7
  70.0%
22
  68.8%
1.Primary Outcome
Title Short Form-36 for Veterans Quality of Life Physical Component Summary Scores
Hide Description

Qualify of life will be determined per Short Form-36 for veterans quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.

immediate intervention and waitlist groups changes compared from baseline and adjusted mean differences at end of 5 weeks.

Time Frame baseline, 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Niacin, Exercise, Sauna, no Intervention
Hide Arm/Group Description:
plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
[Not Specified]
Overall Number of Participants Analyzed 22 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline PCS score 30.3  (8.9) 36.7  (10.5)
5 week PCS scores 38.2  (10.3) 35.7  (12.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Niacin, Exercise, Sauna,, no Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.9
Confidence Interval (2-Sided) 95%
-0.3 to 14.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Fatigue Severity
Hide Description Multidimensional fatigue inventory. change in Self reported fatigue severity. Measures 5 dimensions of fatigue: general, physical, mental, reduced motivation and reduced activity. Scores 4-20 in each dimension, higher score worse fatigue.
Time Frame baseline, 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Niacin, Exercise, Sauna, no Intervention
Hide Arm/Group Description:
plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
[Not Specified]
Overall Number of Participants Analyzed 22 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline fatigue score 17.4  (2.6) 15.3  (5.3)
5 week fatigue score 12.8  (4.8) 15.7  (3.6)
Time Frame 4-6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Niacin, Exercise, Sauna no Intervention Waitlist
Hide Arm/Group Description the immediate intervention group (n=22) completed the step in 4 weeks, received only usual care, followed by (n=10) crossed over to receive the intervention for a 4 week period
All-Cause Mortality
Niacin, Exercise, Sauna no Intervention Waitlist
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Niacin, Exercise, Sauna no Intervention Waitlist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Niacin, Exercise, Sauna no Intervention Waitlist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/22 (13.64%)      0/10 (0.00%)    
Cardiac disorders     
hypotension   2/22 (9.09%)  2 /10 
Metabolism and nutrition disorders     
hypokalemia   1/22 (4.55%)  1 /10 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David O. Carpenter MD
Organization: Institute for Health and the Environment, University at Albany
Phone: 518-525-2660
EMail: dcarpenter@albany.edu
Layout table for additonal information
Responsible Party: David O. Carpenter, University at Albany
ClinicalTrials.gov Identifier: NCT01672710    
Other Study ID Numbers: GW093066
First Submitted: August 15, 2012
First Posted: August 27, 2012
Results First Submitted: July 31, 2018
Results First Posted: December 28, 2018
Last Update Posted: April 13, 2020