Nicotinamide Riboside Clinical Trial for GWI

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Roskamp Institute Inc.
Study ID
NCT05243290
Status
Recruiting

Conditions

  • Gulf War Illness

Eligibility Criteria

Sex
ALL
Age
47 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nicotinamide Riboside — DIETARY_SUPPLEMENT
    The product under investigation, Nicotinamide riboside (NR), is a naturally occurring NAD+ precursor and a member of the vitamin B3 family.
  • Placebo — DIETARY_SUPPLEMENT
    Visually matching placebo capsules will contain the same inactive ingredients present in the manufactured NR capsules, with the exception of any NR compound.

Study Details

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).

Key Dates

Start date
Apr 13, 2022
Status verified
Nov 2024
Primary completion
Apr 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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).

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nova Southeastern UniversityFort LauderdaleFlorida33314
Kamoly Dorneles
(954) 262-1343
Nancy Klimas, MD (PRINCIPAL_INVESTIGATOR)
Amanpreet Cheema, PhD (PRINCIPAL_INVESTIGATOR)
The Roskamp InstituteSarasotaFlorida34243
Dakota Helgager
9412568019
Laila Abdullah, PhD (PRINCIPAL_INVESTIGATOR)
Michael Hoffmann, MD (PRINCIPAL_INVESTIGATOR)

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