NCT05243290

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 24, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

January 27, 2022

Last Update Submit

July 21, 2025

Conditions

Gulf War Illness

Outcome Measures

Primary Outcomes (1)

  • Changes in plasma NAD+ levels

    The primary objective is to determine if NR can increase plasma NAD+ levels in GWI veterans.

    10 weeks

Secondary Outcomes (2)

  • Changes in lipid profiles

    10 weeks

  • Changes in immune biomarker profiles

    10 weeks

Other Outcomes (6)

  • Changes in fatigue

    10 weeks

  • Changes in memory (neurocognitive)

    10 weeks

  • Changes in memory (neuropsychological)

    10 weeks

  • +3 more other outcomes

Study Arms (2)

Study Supplement: NR

ACTIVE COMPARATOR

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.

Dietary Supplement: Nicotinamide Riboside

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Nicotinamide RibosideDIETARY_SUPPLEMENT

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

Study Supplement: NR
PlaceboDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age47 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

RECRUITING

The Roskamp Institute

Sarasota, Florida, 34243, United States

RECRUITING

Related Publications (3)

  • White RF, Steele L, O'Callaghan JP, Sullivan K, Binns JH, Golomb BA, Bloom FE, Bunker JA, Crawford F, Graves JC, Hardie A, Klimas N, Knox M, Meggs WJ, Melling J, Philbert MA, Grashow R. Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: Effects of toxicant exposures during deployment. Cortex. 2016 Jan;74:449-75. doi: 10.1016/j.cortex.2015.08.022. Epub 2015 Sep 25.

    PMID: 26493934BACKGROUND

  • Spector R, Johanson CE. Vitamin transport and homeostasis in mammalian brain: focus on Vitamins B and E. J Neurochem. 2007 Oct;103(2):425-38. doi: 10.1111/j.1471-4159.2007.04773.x. Epub 2007 Jul 20.

    PMID: 17645457BACKGROUND

  • Joshi U, Evans JE, Pearson A, Saltiel N, Cseresznye A, Darcey T, Ojo J, Keegan AP, Oberlin S, Mouzon B, Paris D, Klimas N, Sullivan K, Mullan M, Crawford F, Abdullah L. Targeting sirtuin activity with nicotinamide riboside reduces neuroinflammation in a GWI mouse model. Neurotoxicology. 2020 Jul;79:84-94. doi: 10.1016/j.neuro.2020.04.006. Epub 2020 Apr 25.

    PMID: 32343995BACKGROUND

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Officials

  • Laila Abdullah, PhD

    The Roskamp Institute

    PRINCIPAL INVESTIGATOR

  • Michael Hoffmann, MD

    The Roskamp Institute

    PRINCIPAL INVESTIGATOR

  • Nancy Klimas, MD

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

  • Amanpreet Cheema, PhD

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dakota Helgager

CONTACT

9412568019dhelgager@roskampclinic.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: We will administer either NR or placebo to the study participants over a blinded period of 10 weeks, followed by an open label phase with all participants receiving NR for 5 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 17, 2022

Study Start

April 13, 2022

Primary Completion

April 30, 2025

Study Completion

December 31, 2025

Last Updated

July 24, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)