Nicotinamide Riboside Supplementation in Chronic Kidney Disease
ConditionChronic Kidney Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30+
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Moderate chronic kidney disease not treated with dialysis, defined as eGFR 30-59 mL/min/1.73 m2 using the CKD-EPI equation.
Urine albumin-to-creatinine ratio (uACR) <300 mg/g.
Able to provide informed consent.
Able to walk unassisted from room to room, with usual assistive device allowed if approved by study safety assessment.
Disqualifiers
Pregnancy.
Expectation to start dialysis within 6 months.
Unable to walk unassisted from room to room.
Institutionalization or inability to consent.
Trial design
Design model
Crossover
Treatments tested in this trial
Nicotinamide Riboside (NR)
Dietary supplementNicotinamide riboside will be administered orally at a target dose of 1000 mg/day for 12 weeks during the active treatment period.
Matched Placebo (Capsules)
Dietary supplementMatched 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Placebo Then NRExperimental treatment 1 intervention
Group B: NR Then PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 262
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 26Secondary outcomes
1
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 262
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 263
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 264
Change in Handgrip Strength
Change in handgrip strength, measured in kilograms using handheld dynamometry.
Time frame
Baseline, Week 12, and Week 26Sponsors and contacts
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Source ClinicalTrials.gov
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