Testing Nicotinamide Riboside for Gulf War Illness

A Randomized Double-blind Placebo-controlled Clinical Trial of Nicotinamide Riboside for Restoring Mitochondrial Bioenergetics in Gulf War Illness

This study is testing if taking Nicotinamide Riboside can help veterans with Gulf War Illness feel better by boosting their energy levels and improving symptoms like fatigue and memory problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 47 Years to 70 Years
• Sex: All
• Sponsor: Roskamp Institute Inc. (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Fort Lauderdale, Florida and 1 other locations)
• Trial ID: NCT05243290 on ClinicalTrials.gov

What this trial studies

This multi-site clinical trial aims to evaluate the effectiveness of 300 mg of Nicotinamide Riboside (NR) in increasing plasma NAD+ levels in veterans suffering from Gulf War Illness (GWI). Utilizing a randomized, double-blind, placebo-controlled design, the study will assess whether NR supplementation can alleviate symptoms associated with GWI, such as fatigue and memory impairment. The trial is based on previous findings that indicate lower NAD+ levels in GWI patients compared to healthy controls, suggesting a potential bioenergetic deficit. Participants will be closely monitored for safety and efficacy throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates for this study are veterans who were deployed during the Gulf War and meet the criteria for Chronic Multisymptom Illness.

Not a fit: Patients who are not veterans of the Gulf War or do not meet the specific diagnostic criteria for GWI may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for veterans suffering from Gulf War Illness by alleviating debilitating symptoms.

How similar studies have performed: While the approach of using Nicotinamide Riboside is promising, it is relatively novel in the context of Gulf War Illness, with limited prior studies specifically targeting this condition.

Eligibility criteria

Inclusion Criteria:

* Both sexes, all ethnic groups, and ages 47 to 70 years.
* Subject willing and able to give informed consent.
* Medically stable as per the investigator's discretion.
* Negative urine pregnancy test for females of childbearing potential. A woman is considered of childbearing potential unless she is surgically sterile (hysterectomy or tubal ligation) or is postmenopausal (no menstrual cycle for 2 years or more).
* If female of childbearing potential, must be willing to use adequate birth control during the study and for 30 days after the last dose. Females agreeing to take an acceptable form of birth control per investigator discretion (where relevant). Females must prevent pregnancy or otherwise be unable to conceive.
* Veterans deployed to the Gulf War between August 1990 and August 1991.
* Veteran meets criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition.
* Weight of 50.0kg - 200.0kg (110 lbs. - 440 lbs.).

Exclusion Criteria:

* Diagnosed by a physician with medical or psychiatric conditions that would account for their symptoms or interfere with their ability to report their symptoms, as per investigator discretion.
* Female subject is either pregnant or nursing; or if female subject is of childbearing age is not currently on or is unwilling and/or unable to use birth control.
* Have contraindications, allergy, or sensitivity to NR, vitamin B3, or excipients (microcrystalline cellulose, silicon dioxide, magnesium stearate, hypromellose, and/or titanium dioxide).
* Any significant medical condition that could interfere with study conduct, as per investigator discretion. These may include but are not limited to the following: untreated chronic hypertension (defined as systolic \> 180 mmHg; diastolic \>110 mmHg), myocardial infarction within 6 months of screening, renal failure, hepatic failure, and/or receiving chemotherapy.
* Clinically significant lab values for clinical laboratory assessments, as per investigator discretion.
* Poor venous access.
* Current use of any NR supplement products (such as nicotinamide, nicotinamide mononucleotide (NMN), vitamin B3/Niacin, vitamin B complex, etc.) within 30 days of screening.
* Participation in another clinical trial involving dietary or pharmaceutical intervention within 90 days of screening.

Where this trial is running

Fort Lauderdale, Florida and 1 other locations

• Nova Southeastern University — Fort Lauderdale, Florida, United States (Recruiting)
• The Roskamp Institute — Sarasota, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Laila Abdullah, PhD — The Roskamp Institute
• Study coordinator: Dakota Helgager

Conditions Gulf War Illness