Nicotinamide Riboside Clinical Trial for GWI

Description

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).

Conditions

Gulf War Illness

Study Overview

Study Details

Study overview

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).

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

Nicotinamide Riboside Clinical Trial for GWI

Condition
Gulf War Illness
Intervention / Treatment

-

Contacts and Locations

Fort Lauderdale

Nova Southeastern University, Fort Lauderdale, Florida, United States, 33314

Sarasota

The Roskamp Institute, Sarasota, Florida, United States, 34243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.).
  • * 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.

Ages Eligible for Study

47 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Roskamp Institute Inc.,

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

Study Record Dates

2025-02-15