RECRUITING

Nicotinamide Riboside Clinical Trial for GWI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Randomized Double-blind Placebo-controlled Clinical Trial of Nicotinamide Riboside for Restoring Mitochondrial Bioenergetics in Gulf War Illness

Quick Facts

Study Start:2022-04-13

Study Completion:2025-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05243290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:47 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 cycle for 2 years or more). * 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 discretion (where relevant). Females must prevent pregnancy or otherwise be unable to conceive. * 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 \> 180 mmHg; diastolic \>110 mmHg), myocardial infarction within 6 months of screening, renal failure, hepatic failure, and/or receiving chemotherapy. * 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.

Inclusion Criteria

Exclusion 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 cycle for 2 years or more).
* 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 discretion (where relevant). Females must prevent pregnancy or otherwise be unable to conceive.
* 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 \> 180 mmHg; diastolic \>110 mmHg), myocardial infarction within 6 months of screening, renal failure, hepatic failure, and/or receiving chemotherapy.
* 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.

Contacts and Locations

Study Contact

Dakota Helgager

CONTACT

9412568019

dhelgager@roskampclinic.org

Principal Investigator

Laila Abdullah, PhD

PRINCIPAL_INVESTIGATOR

The Roskamp Institute

Michael Hoffmann, MD

PRINCIPAL_INVESTIGATOR

The Roskamp Institute

Nancy Klimas, MD

PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Amanpreet Cheema, PhD

PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Study Locations (Sites)

Nova Southeastern University

Fort Lauderdale, Florida, 33314

United States

The Roskamp Institute

Sarasota, Florida, 34243

United States

Collaborators and Investigators

Sponsor: Roskamp Institute Inc.

Laila Abdullah, PhD, PRINCIPAL_INVESTIGATOR, The Roskamp Institute
Michael Hoffmann, MD, PRINCIPAL_INVESTIGATOR, The Roskamp Institute
Nancy Klimas, MD, PRINCIPAL_INVESTIGATOR, Nova Southeastern University
Amanpreet Cheema, PhD, PRINCIPAL_INVESTIGATOR, Nova Southeastern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-13

Study Completion Date2025-02-15

Study Record Updates

Study Start Date2022-04-13

Study Completion Date2025-02-15

Terms related to this study

Additional Relevant MeSH Terms

Gulf War Illness