NAD+ and Exercise in FA (NCT04192136) | Clinical Trial Compass
CompletedNot Applicable
NAD+ and Exercise in FA
United States75 participantsStarted 2020-09-03
Plain-language summary
Randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on Peak VO2 and Si in Friedreich's Ataxia (FA).
The primary objective of this research is to measure the effect of combination administration (NR + exercise) on aerobic capacity (Peak VO2) in FA. A key secondary objective is to measure the effect of combination administration (NR + exercise) on glucose homeostasis (Si) in FA.
Who can participate
Age range10 Years – 40 Years
SexALL
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Inclusion criteria
✓. Molecular diagnosis of Friedrich's Ataxia (FA).
✓. Males and Females, Age 10 to 40 years (inclusive).
✓. Girls, 11 years of age and older, must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
✓. Not currently meeting exercise guidelines as outlined by The Physical Activity Guidelines for Americans.
✓. Cardiac echocardiogram or cardiac MRI, performed within 1 year of enrollment, showing an LVEF \> 45%
✓. ECG, performed within 1 year of enrollment, without clinically significant arrhythmia.
✓. Weight \> 24 kg
✓. Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion criteria
✕. Known sensitivity to NR.
✕. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity.