Nicotinamide Riboside Clinical Trial for GWI

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

The 1991 Gulf War (GW) was fought by a coalition of 30 countries that included 700,000 U.S. troops. Although the war itself lasted two months, adverse health consequences from this conflict are still experienced by GW veterans. Soon after their return, many soldiers started reporting multiple, seemingly unrelated symptoms, such as memory impairment, fatigue, gastrointestinal problems, and widespread pain. This illness, termed Gulf War Illness (GWI), affects about 32% of GW veterans. Several preclinical studies suggest the presence of bioenergetic deficits in the blood and brains of veterans with GWI, as well as in the mouse models of this illness. The investigators' recent work shows that plasma levels of bioenergetic metabolites, such as nicotinamide adenine dinucleotide (NAD+), are lower in veterans with GWI compared to healthy GW controls. This corresponds with low Sirt1 levels in the peripheral blood mononuclear cells (PBMC) from veterans with GWI. Given the importance of NAD+ in cellular bioenergetics, various approaches have been explored for supplementing NAD+. Among these, supplementation with the NAD+ precursor nicotinamide riboside (NR) appears to be a viable option, since this form of NAD+ can enter the cell and cross the blood-brain-barrier. The investigators' recent animal studies show that supplementation with NR, a member of the vitamin B3 family, can correct the bioenergetic deficits in GWI mice, which corresponds with an improvement in fatigue-type behavior that is commonly reported by veterans with GWI. The main objective of this project is to determine, through the use of metabolomics and biochemical assays, if NR supplementation can maintain a healthy bioenergetic profile in the blood of veterans with GWI. The secondary objective is to determine if NR can maintain healthy blood lipid and immune biomarker profiles in GWI veterans. The study will also explore whether NR can improve general health and well-being of veterans with GWI. ;

Study Design

Related Conditions & MeSH terms

Gulf War Illness

Clinical Trial Details

NCT number	NCT05243290
Study type	Interventional
Source	Roskamp Institute Inc.
Contact	Dakota Helgager
Phone	9412568019
Email	dhelgager@roskampclinic.org
Status	Recruiting
Phase	N/A
Start date	April 13, 2022
Completion date	February 15, 2025

View Details

See also
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Terminated	`NCT02011542` - Probiotic (VSL #3) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT03078530` - Probiotic (Visbiome) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT04058275` - "Immunomodulation in GWI (Phlebotomy)"
Recruiting	`NCT04255498` - Understanding GWI: Integrative Modeling	Phase 1
Completed	`NCT02782780` - Cognitive Behavioral Therapy for Insomnia for Gulf War Illness	N/A
Recruiting	`NCT02983734` - D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)	Phase 2
Recruiting	`NCT05972291` - Mechanisms of Gulf War Illness	N/A
Recruiting	`NCT04182659` - Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms	N/A
Recruiting	`NCT04046536` - rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)	N/A
Recruiting	`NCT05675878` - Confirmation of Diet as a Treatment for Gulf War Illness	Phase 3
Recruiting	`NCT05736146` - Validating Gulf War Illness Blood Biomarkers
Not yet recruiting	`NCT05820893` - Resistant Potato Starch to Alleviate GWI	Phase 2
Terminated	`NCT01846182` - Research Examining Gulf War Illness in Our Nations Service Members	Phase 2
Active, not recruiting	`NCT05252949` - OEA for Targeting Lipid Metabolism in GWI	N/A
Completed	`NCT02378025` - Treating Chronic Pain in Gulf War Illness	N/A
Completed	`NCT02865460` - Coenzyme Q10 Phase III Trial in Gulf War Illness	Phase 3
Completed	`NCT02909686` - Effects of Botanical Microglia Modulators in Gulf War Illness	N/A
Completed	`NCT01291758` - Exercise in Gulf War Illness (GWI)
Completed	`NCT01011348` - Q10 for Gulf War Veterans	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.