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Nicotinamide Riboside Clinical Trial for GWI

RecruitingNAAges 47 Years - 70 YearsAllRoskamp Institute Inc.
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In plain words

What the trial is, and whether it could suit you

In this multi-site trial, we will use a randomized, double-blind, placebo-controlled study design to test whether 300 mg of Nicotinamide Riboside (NR) can achieve the primary objective of increasing plasma NAD+ levels in participants with Gulf War Illness (GWI).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Nicotinamide Riboside
  • Placebo
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Where

2 sites
Nova Southeastern University
Fort Lauderdale, United States
The Roskamp Institute
Sarasota, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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