What side effects are associated with this type of intervention?

Common treatments for Gulf War Syndrome include medications aimed at alleviating symptoms such as pain, fatigue, and cognitive dysfunction. Nicotinamide Riboside, which increases NAD+ levels, is being studied for its potential benefits. Known side effects of similar treatments that aim to boost cellular energy and reduce oxidative stress can include gastrointestinal issues, headaches, and mild skin reactions. It is important for patients to discuss these potential side effects with their healthcare provider to tailor the treatment to their specific needs.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically for Gulf War Syndrome that focus on increasing NAD+ levels, such as Nicotinamide Riboside. Generally, treatments for Gulf War Syndrome have included a variety of approaches targeting symptoms like pain, fatigue, and cognitive dysfunction. These treatments often involve medications, physical therapy, and psychological support. The ongoing trial of Nicotinamide Riboside aims to explore its potential benefits by increasing NAD+ levels, which may help improve cellular energy metabolism and overall health in affected individuals.

What other types of research exist?

Promising alternatives to Nicotinamide Riboside for Gulf War Syndrome patients include Nicotinamide Mononucleotide (NMN), which is another NAD+ precursor, and MitoQ, a mitochondrial-targeted antioxidant. Both have shown potential in enhancing mitochondrial function and reducing oxidative stress, which are relevant to the symptoms of GWS.

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Vitamin

Nicotinamide Riboside for Gulf War Syndrome

N/A

Recruiting

Led By Michael Hoffmann, MD

Research Sponsored by Roskamp Institute Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.)

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

Summary

This trial tests whether taking Nicotinamide Riboside (NR), a form of vitamin B3, can help veterans with Gulf War Illness (GWI). GWI causes symptoms like fatigue and pain, possibly due to low energy levels in cells. NR aims to increase a molecule called NAD+ in the blood, which is crucial for cell energy production. The goal is to see if this can improve the health and well-being of these veterans. Nicotinamide Riboside (NR) is a newly discovered nicotinamide adenine dinucleotide (NAD+) precursor vitamin, recognized as safe for use in foods and dietary supplements.

Who is the study for?

This trial is for Gulf War veterans aged 47-70 with Gulf War Illness, who are medically stable and not on certain supplements. Women must use birth control if of childbearing potential. Those with allergies to the study drug or significant health issues can't participate.

What is being tested?

The trial tests if Nicotinamide Riboside (NR) increases plasma NAD+ levels in GWI patients using a double-blind method where neither participants nor researchers know who gets NR or placebo until after results are collected.

What are the potential side effects?

While specific side effects aren't listed here, NR is generally considered safe but could potentially cause mild upset stomach, fatigue, headaches, diarrhea, or indigestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a veteran diagnosed with Gulf War Illness according to CDC or Kansas criteria.

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My weight is between 110 lbs and 440 lbs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, nursing, and if of childbearing age, I am using or willing to use birth control.

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I am allergic to NR, vitamin B3, or certain pill ingredients.

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I do not have any major health issues that could affect the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in plasma NAD+ levels

Secondary study objectives

Changes in immune biomarker profiles

Changes in lipid profiles

Other study objectives

Fatigue

Changes in general well-being

Memory

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Study Supplement: NRActive Control1 Intervention

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.

Group II: ControlPlacebo Group1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Gulf War Syndrome (GWS) often focus on improving cellular energy production and reducing oxidative stress, similar to the mechanism of Nicotinamide Riboside (NR). NR increases NAD+ levels, a coenzyme essential for mitochondrial function and energy metabolism. This can enhance mitochondrial efficiency, reduce oxidative damage, and support cellular repair processes. These mechanisms are crucial for GWS patients, who frequently experience chronic fatigue, muscle pain, and cognitive impairments, potentially due to mitochondrial dysfunction and oxidative stress. By targeting these underlying issues, treatments like NR may help alleviate the symptoms and improve the quality of life for GWS patients.

The metabolism of glyceryl trinitrate to nitric oxide in the macrophage cell line J774 and its induction by Escherichia coli lipopolysaccharide.Potentiation of retinoic acid-induced U-937 differentiation into respiratory burst-competent cells by nitric oxide donors.Soluble guanylyl cyclase (sGC) degradation and impairment of nitric oxide-mediated responses in urethra from obese mice: reversal by the sGC activator BAY 60-2770.