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New treatment option for Gulf War Illness
Official title Nicotinamide Riboside Clinical Trial for GWI
ClinicalTrials.gov ID: NCT05243290
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 47 to 70
You may be able to join 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...
- 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...
You likely can't join if
- Diagnosed by a physician with medical or psychiatric conditions that would account for their symptoms or interfere with their ability to report their...
- 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...
- Have contraindications, allergy, or sensitivity to NR, vitamin B3, or excipients (microcrystalline cellulose, silicon dioxide, magnesium stearate...
- Any significant medical condition that could interfere with study conduct, as per investigator discretion. These may include but are not limited to...
- Clinically significant lab values for clinical laboratory assessments, as per investigator discretion.
- Poor venous access.
See the full eligibility criteria
- 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...
- 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...
- 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.).
- 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 \>...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Lauderdale, Florida, United States
- Sarasota, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 47 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Lauderdale, Florida, United States; Sarasota, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.