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Search / Trial NCT05243290

Nicotinamide Riboside Clinical Trial for GWI

Launched by ROSKAMP INSTITUTE INC. · Feb 14, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called Nicotinamide Riboside (NR) on veterans who have Gulf War Illness (GWI). The goal is to see if taking 300 mg of NR can increase levels of a substance in the blood called NAD+, which may help improve symptoms related to GWI. The trial is currently looking for participants aged 47 to 70 who are veterans deployed during the Gulf War between August 1990 and August 1991. To qualify, participants must be in good health, able to give consent, and meet specific health criteria.

If you join the trial, you will be randomly assigned to either receive the NR supplement or a placebo (a pill that looks the same but doesn’t contain the active ingredient) without knowing which one you’re taking. This is to ensure that the results are fair and unbiased. Participants will also be monitored throughout the study to assess their health and any changes in symptoms. It’s important to note that women who can become pregnant will need to use birth control during the study. This trial aims to gather valuable information that could potentially lead to better treatments for Gulf War Illness.

Gender

ALL

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.

About Roskamp Institute Inc.

Roskamp Institute Inc. is a leading nonprofit research organization dedicated to advancing the understanding and treatment of neurocognitive disorders, primarily focusing on Alzheimer's disease and related conditions. With a commitment to innovative research and clinical trials, the Institute collaborates with esteemed academic institutions and industry partners to develop novel therapeutic approaches. Its multidisciplinary team of experts combines clinical expertise with cutting-edge scientific methodologies, striving to translate research findings into effective interventions that improve patient outcomes and enhance quality of life. Through its rigorous approach to clinical investigation, Roskamp Institute Inc. aims to contribute significantly to the field of neurodegenerative disease research and treatment.

Locations

Fort Lauderdale, Florida, United States

Sarasota, Florida, United States

Patients applied

0 patients applied

Trial Officials

Laila Abdullah, PhD

Principal Investigator

The Roskamp Institute

Michael Hoffmann, MD

Principal Investigator

The Roskamp Institute

Nancy Klimas, MD

Principal Investigator

Nova Southeastern University

Amanpreet Cheema, PhD

Principal Investigator

Nova Southeastern University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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