Niacin Supplementation in Healthy Controls and Mitochondrial Myopathy Patients

Plain-language summary

This study examined Niacin (vitamin B3) supplementation in patients with mitochondrial myopathy, a muscle disease caused by mtDNA deletions, and in healthy controls. Patients with pure mitochondrial myopathy due to mtDNA deletions and age- and sex-matched healthy volunteers were eligible. The study had no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Helsinki

Intervention

Niacin

Start date

6/1/2014

Estimated completion

12/31/2018

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Manifestation of pure mitochondrial myopathy, with no major other symptoms or manifestations, caused by single or multiple deletions of mtDNA
2. Age and gender matched healthy controls for every patient
3. Agreed to avoid vitamin supplementation or nutritional products with vitamin B3 forms 14 days prior to the enrollment and during the study
4. Written, informed consent to participate in the study

Exclusion Criteria:

1. Inability to follow study protocol
2. Pregnancy or breast-feeding at any time of the trial
3. Malignancy that requires continuous treatment
4. Unstable heart disease
5. Severe kidney disease requiring treatment
6. Severe encephalopathy
7. Regular usage of intoxicants