ACTIVE_NOT_RECRUITING

A Study to Evaluate Vitamin B3 Derivative to Treat Mitochondrial Myopathy

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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

The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplement in adult-onset symptoms of mitochondrial myopathy.

Official Title

Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy of Nicotinamide Riboside (NR) - a Vitamin B3 Derivative - for Treatment of Mitochondrial Myopathy Disorder

Quick Facts

Study Start:2023-05-26

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05590468

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Biochemically and/or genetically confirmed or confirmed primary mitochondrial myopathy based on published diagnostic criteria. * Biochemically confirmed mitochondrial disorder would mean that the patient meets clinical criteria and has either biopsy or biochemical testing that supports the diagnosis. * Confirmed mitochondrial disorder means that the patient meets published clinical criteria for the diagnosis and has also had confirmatory genetic testing for the disorder type. * Agreed to avoid vitamin supplementation or nutritional products with vitamin B3 forms 14 days prior to the enrollment and during the study in order to not exceed 200 mg/day of vitamin B3 derivatives intake. * Female of childbearing potential agreed to use effective contraception throughout the study. * Written, informed consent to participate in the study.	* Unwilling to comply with the follow-up schedule. * Inability or refusal to give informed consent by the patient or a legally authorized representative. * Known pregnancy or breastfeeding. * Concurrent participation in another investigational drug study or within washout period of treatment. * Presence of other medical symptoms or condition, which may interfere with interpretation of outcome measures as determined by the study PI.

Inclusion Criteria

Exclusion Criteria

* Biochemically and/or genetically confirmed or confirmed primary mitochondrial myopathy based on published diagnostic criteria.
* Biochemically confirmed mitochondrial disorder would mean that the patient meets clinical criteria and has either biopsy or biochemical testing that supports the diagnosis.
* Confirmed mitochondrial disorder means that the patient meets published clinical criteria for the diagnosis and has also had confirmatory genetic testing for the disorder type.
* Agreed to avoid vitamin supplementation or nutritional products with vitamin B3 forms 14 days prior to the enrollment and during the study in order to not exceed 200 mg/day of vitamin B3 derivatives intake.
* Female of childbearing potential agreed to use effective contraception throughout the study.
* Written, informed consent to participate in the study.

* Unwilling to comply with the follow-up schedule.
* Inability or refusal to give informed consent by the patient or a legally authorized representative.
* Known pregnancy or breastfeeding.
* Concurrent participation in another investigational drug study or within washout period of treatment.
* Presence of other medical symptoms or condition, which may interfere with interpretation of outcome measures as determined by the study PI.

Contacts and Locations

Principal Investigator

Ralitza H. Gavrilova, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Ralitza Gavrilova

Ralitza H. Gavrilova, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2023-05-26

Study Completion Date2025-11

Study Record Updates

Study Start Date2023-05-26

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Mitochondrial Myopathy