Testing Nicotinamide Riboside for Gulf War Illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dhelgager@roskampclinic.org
• Phone: 9412568019

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using machine learning to guide rTMS for Gulf War Illness–related headaches and body pain

  This trial will try using a machine learning model on resting brain scans to predict which active rTMS treatment will best reduce headaches and body pain in veterans with Gulf War Illness.

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• Exploring treatments for Gulf War Illness-related gastrointestinal symptoms

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• Using resistant potato starch to help veterans with Gulf War Illness

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  Recruiting Phase 2 VA Office of Research and Development · Madison, Wisconsin · NCT05820893

• Identifying blood biomarkers for Gulf War Illness

  This study is trying to find specific blood markers in veterans with Gulf War Illness to see how they relate to memory problems and other brain issues.

  Recruiting at 3 sites Roskamp Institute Inc. · Palo Alto, California and 2 other locations · NCT05736146

• Investigating Gulf War Illness in Veterans

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  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05375812

• Butyrate treatment for Gulf War Illness

  This study is testing if a butyrate treatment can help improve physical function and reduce symptoms in Veterans with Gulf War Illness.

  Recruiting at 3 sites Phase 2 VA Office of Research and Development · Long Beach, California and 2 other locations · NCT05367245

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.