Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: Effects of toxicant exposures during deployment.
Roberta F White, Lea Steele, James P O'Callaghan...
https://pubmed.ncbi.nlm.nih.gov/26493934Actively Recruiting
Phase Not Applicable
Age: 47Years - 70Years
All Genders
ID05243290
A Randomized Double-blind Placebo-controlled Trial of Nicotinamide Riboside for Mitochondrial Bioenergetics in Gulf War Illness
Led by Roskamp Institute Inc. · Updated on 2025-07-24
52
Participants Needed
2
Research Sites
35 weeks
Total Duration
On this page
Sponsors
R
Roskamp Institute Inc.
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a daily 300 mg dose of Nicotinamide Riboside (NR), a vitamin B3 family supplement, can increase plasma NAD+ levels in veterans affected by Gulf War Illness (GWI). GWI is a condition affecting about 32% of Gulf War veterans, causing symptoms like memory problems, fatigue, gastrointestinal issues, and widespread pain. The study aims to understand how NR may influence bioenergetic and immune functions in these veterans. Participants are randomly assigned to one of two groups in a double-blind design: one group receives 300 mg of NR daily for 10 weeks, while the other group receives a placebo. The study evaluates changes in plasma NAD+ as the primary outcome and also measures lipid and immune biomarker profiles. Both groups are monitored closely during this 10-week treatment phase. During the study, veterans will have regular assessments including blood tests to measure NAD+ and other biomarkers. Researchers will also evaluate general health and well-being. The study collects data over the 10-week period to determine if NR supplementation supports healthier bioenergetic profiles. Safety and adherence to the treatment are monitored throughout the trial, which enrolls veterans aged 47 to 70 years with GWI.
CONDITIONS
Brief Title
Nicotinamide Riboside Clinical Trial for GWI
Who Can Participate
Age: 47Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Ages 47 to 70 years
- Both sexes and all ethnic groups
- Willing and able to give informed consent
- Medically stable as judged by the investigator
- Negative urine pregnancy test for females of childbearing potential
- Females of childbearing potential must use adequate birth control during the study and for 30 days after last dose
- Veterans deployed to the Gulf War between August 1990 and August 1991
- Meet criteria for the CDC Chronic Multisymptom Illness or Kansas Gulf War Illness definition
- Weight between 50.0 kg and 200.0 kg (110 lbs to 440 lbs)
You will not qualify if you...
- Diagnosed with medical or psychiatric conditions that explain symptoms or interfere with symptom reporting
- Pregnant or nursing females, or females not using birth control if of childbearing potential
- Allergy or sensitivity to nicotinamide riboside, vitamin B3, or capsule ingredients
- Significant medical conditions interfering with study, including untreated severe hypertension, recent heart attack, renal or liver failure, or chemotherapy
- Abnormal clinical lab values as judged by investigator
- Poor venous access
- Current use of nicotinamide riboside or related supplements within 30 days
- Participation in another dietary or pharmaceutical clinical trial within 90 days prior to screening
AI-Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 10 weeks
Participants take either nicotinamide riboside or placebo once daily to evaluate its effect on bioenergetic profiles and general health.
Weekly visits for up to 10 weeks
Trial Site Locations
Total: 2 locations
1
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314
Actively Recruiting
2
The Roskamp Institute
Sarasota, Florida, United States, 34243
Actively Recruiting
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Research Team
D
Dakota Helgager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Vitamin transport and homeostasis in mammalian brain: focus on Vitamins B and E.
Reynold Spector, Conrad E Johanson
https://pubmed.ncbi.nlm.nih.gov/17645457Targeting sirtuin activity with nicotinamide riboside reduces neuroinflammation in a GWI mouse model.
Utsav Joshi, James E Evans, Andrew Pearson...
https://pubmed.ncbi.nlm.nih.gov/32343995