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Nicotinamide Riboside Clinical Trial for GWI
Plain-language guide to NCT05243290: not phased randomized trial of NAD+, 52 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05243290
- Phase
- not phased
- Status
- recruiting participants
- Start
- 2022-04-13
- Completion (planned or actual)
- 2025-04-30
- Participants
- 52 (estimated)
- Design
- randomized, quadruple-blind, supportive_care
- Conditions studied
- Gulf War Illness
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested NAD+.
It had two arms (groups): Study Supplement: NR (active comparator) and Control (placebo comparator).
26 subjects will take the placebo during the first phase of the study (10 weeks).
The registry classes the interventions as dietary supplement.
More on the Plan
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.
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.
Who Took Part
The registry lists 52 planned participants were the target.
It was open to people of any sex aged from 47 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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. 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.
The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: have contraindications, allergy, or sensitivity to nr, vitamin b3, or excipients (microcrystalline cellulose, silicon dioxide, magnesium stearate, hypromellose, and/or titanium dioxide); 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.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received NAD+.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2022-04-13 with completion listed for 2025-04-30.
It ran at 2 sites in United States (2).
Its stated primary purpose is supportive care.
What Was Measured
Primary outcome: Changes in plasma NAD+ levels (time frame: 10 weeks).
It also tracked 2 secondary outcomes, for example Changes in lipid profiles and Changes in immune biomarker profiles.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 52 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.