Recruiting

Nicotinamide Riboside

Sponsor:

Roskamp Institute Inc.

Code:

NCT05243290

Conditions

Gulf War Illness

Eligibility Criteria

Sex: All

Age: 47 - 70

Healthy Volunteers: Not accepted

Interventions

Nicotinamide Riboside

Placebo

Study Details

Brief summary:

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 ID

NCT05243290

Start date

Apr 13, 2022

Status verified date

Nov, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Apr 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 47 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Study Supplement: NR

26 subjects will take the supplement (nicotinamide riboside) during the first phase of the study. 300mg will be taken once a day for the 10-week period in phase one.

placebo comparator: Control

26 subjects will take the placebo during the first phase of the study (10 weeks).

Interventions

Nicotinamide Riboside

The product under investigation, Nicotinamide riboside (NR), is a naturally occurring NAD+ precursor and a member of the vitamin B3 family.

Placebo

Visually matching placebo capsules will contain the same inactive ingredients present in the manufactured NR capsules, with the exception of any NR compound.

Primary outcome measure

  • Changes in plasma NAD+ levels [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Dakota Helgager

9412568019dhelgager@roskampclinic.org

Locations

Nova Southeastern University

Recruiting

Fort Lauderdale, Florida, United States, 33314

Contacts

Kamoly Dorneles

(954) 262-1343kdornele@nova.edu

Principal Investigator:

Nancy Klimas, MD

The Roskamp Institute

Recruiting

Sarasota, Florida, United States, 34243

Contacts

Dakota Helgager

9412568019dhelgager@roskampclinic.org

Principal Investigator:

Laila Abdullah, PhD

More Information

Sponsor

Roskamp Institute Inc.

Last update posted

Jul 24, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Roskamp Institute Inc. on 2025-07-24.