This study is testing whether a dietary supplement called nicotinamide riboside, (NR), can be used in adults with moderate chronic kidney disease. NR is a form of vitamin B3 that may help support cellular energy metabolism. The main goal of this study is to see whether it is feasible for people with chronic kidney disease to take NR daily, complete study visits, and follow the study procedures. The study will also explore whether NR chloride affects markers of mitochondrial health, small blood vessel function, and physical function. Participants will be randomly assigned to one of two treatment orders. One group will take NR first and placebo second. The other group will take placebo first and NR second. Placebo looks like NR but does not contain active NR. Each treatment period lasts 12 weeks, with an approximately 2-week washout period between treatments. Neither participants nor the study team will know which treatment participants are taking during each period. Study visits will include blood and urine collection, physical function testing, and noninvasive tests of small blood vessel function. The study will enroll up to 36 adults with moderate chronic kidney disease at the University of California, San Diego.
Chronic kidney disease is associated with impaired mitochondrial function, vascular dysfunction, reduced physical function, and increased risk of cardiovascular and functional decline. Nicotinamide riboside is a vitamin B3 derivative and NAD+ precursor that may support cellular energy metabolism and vascular health. This pilot study will evaluate the feasibility of using nicotinamide riboside in adults with moderate chronic kidney disease. The study uses a randomized, double-blind, placebo-controlled crossover design so that each participant receives both nicotinamide riboside chloride and placebo during separate treatment periods. In addition to feasibility measures, the study will collect exploratory data on mitochondrial, microvascular, and physical function outcomes. These data will help determine whether a larger clinical trial of nicotinamide riboside in chronic kidney disease is practical and scientifically justified.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Nicotinamide riboside will be administered orally at a target dose of 1000 mg/day for 12 weeks during the active treatment period.
Matched placebo will be administered orally for 12 weeks during the placebo treatment period. The placebo will be identical or substantially similar in appearance to the active nicotinamide riboside study product to maintain blinding.
Altman Clinical and Translation Research Institute
San Diego, California, United States
Change in plasma cell-free mitochondrial DNA
Change in plasma cell-free mitochondrial DNA concentration, measured as mitochondrial DNA copies per mL of plasma using droplet digital PCR.
Time frame: Baseline, Week 12, and Week 26
Change in urine cell-free mitochondrial DNA
Change in urine cell-free mitochondrial DNA concentration, measured using droplet digital PCR and reported as mitochondrial DNA copies normalized to urine osmolarity.
Time frame: Baseline, Week 12, and Week 26
Change in skin fingernail capillary density
Change in skin capillary density, measured as capillaries per mm2 using capillaroscopy.
Time frame: Baseline, Week 12, and Week 26
Change in skin blood flow
Change in skin blood flow, measured in laser Doppler perfusion units using laser Doppler flowmetry.
Time frame: Baseline, Week 12, and Week 26
Change in six-minute walk distance
Change in distance walked during the six-minute walk test, measured in meters.
Time frame: Baseline, Week 12, and Week 26
Change in Handgrip Strength
Change in handgrip strength, measured in kilograms using handheld dynamometry.
Time frame: Baseline, Week 12, and Week 26
Change in Timed Up and Go
Change in Timed Up and Go test performance, measured in seconds.
Time frame: Baseline, Week 12, and Week 26
Change in 30-second sit-to-stand
Change in the number of chair stands completed during the 30-second sit-to-stand test, measured as repetitions completed in 30 seconds.
Time frame: Baseline, Week 12, and Week 26
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