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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01DK147652 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Then NR | Experimental | Participants assigned to this arm will receive matched placebo for 12 weeks, followed by an approximately 14-day washout/crossover period, then nicotinamide riboside 1000 mg/day for 12 weeks. |
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| NR Then Placebo | Experimental | Participants assigned to this arm will receive nicotinamide riboside 1000 mg/day for 12 weeks, followed by an approximately 14-day washout/crossover period, then matched placebo for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide Riboside (NR) | Dietary Supplement | Nicotinamide riboside will be administered orally at a target dose of 1000 mg/day for 12 weeks during the active treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Percentage of eligible approached participants who consent and are randomized. | From study opening to completion of enrollment, up to 18 months |
| Retention Rate | Percentage of randomized participants who complete both treatment periods and the Week 26 final study visit. | Through the end of the study period; Week 26 |
| Study Product Adherence | Adherence will be assessed using study product dispensing and return records, pill count or participant-reported remaining product, and monthly adherence calls. Adherence success is defined as taking at least 75% of prescribed doses during a treatment period. | Weeks 12 and 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12, and Week 26 |
| Change in urine cell-free mitochondrial DNA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armin Ahmadi, PhD | Contact | 619-543-6248 | a3ahmadi@ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Armin Ahmadi, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translation Research Institute | San Diego | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27721479 | Background | Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948. | |
| 29599478 | Background | Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, Chonchol M, Seals DR. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038/s41467-018-03421-7. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Participants will be randomized 1:1 to one of two blinded crossover sequences: NR followed by placebo, or placebo followed by NR. Each treatment period will last 12 weeks, separated by an approximately 14-day washout/crossover period.
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| Matched Placebo (Capsules) | Dietary Supplement | 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. |
|
Change in urine cell-free mitochondrial DNA concentration, measured using droplet digital PCR and reported as mitochondrial DNA copies normalized to urine osmolarity. |
| Baseline, Week 12, and Week 26 |
| Change in skin fingernail capillary density | Change in skin capillary density, measured as capillaries per mm2 using capillaroscopy. | 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. | 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. | Baseline, Week 12, and Week 26 |
| Change in Handgrip Strength | Change in handgrip strength, measured in kilograms using handheld dynamometry. | Baseline, Week 12, and Week 26 |
| Change in Timed Up and Go | Change in Timed Up and Go test performance, measured in seconds. | 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. | Baseline, Week 12, and Week 26 |
| 31278280 | Background | Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |