Nicotinamide Riboside Supplementation in Chronic Kidney Disease (NR-CKD)
Pilot Randomized Crossover Trial of Nicotinamide Riboside in Chronic Kidney Disease (NR-CKD 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Armin Ahmadi, PhD
- Telefonní číslo: 619-543-6248
- E-mail: a3ahmadi@ucsd.edu
Studijní místa
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California
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San Diego, California, Spojené státy, 92093
- Altman Clinical and Translation Research Institute
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Kontakt:
- Armin Ahmadi, PhD
- Telefonní číslo: (619) 543-6248
- E-mail: a3ahmadi@ucsd.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
- Willing and able to comply with study procedures, visits, and study product administration.
Exclusion Criteria:
- Pregnancy.
- Expectation to start dialysis within 6 months.
- Unable to walk unassisted from room to room.
- Institutionalization or inability to consent.
- End-stage liver disease with cirrhosis.
- HIV.
- Oxygen-dependent COPD.
- Baseline systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg.
- Current participation in another interventional trial.
- Use of immunosuppressive medications, including steroids or calcineurin inhibitors.
- Malignancy requiring active treatment or currently under surveillance at the discretion of the investigator.
- Hospitalization for myocardial infarction, unstable angina, cerebrovascular accident, or unstable cardiac chest pain within the prior 3 months.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Placebo Then NR
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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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.
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Experimentální: NR Then Placebo
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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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Recruitment Rate
Časové okno: From study opening to completion of enrollment, up to 18 months
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Percentage of eligible approached participants who consent and are randomized.
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From study opening to completion of enrollment, up to 18 months
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Retention Rate
Časové okno: Through the end of the study period; Week 26
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Percentage of randomized participants who complete both treatment periods and the Week 26 final study visit.
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Through the end of the study period; Week 26
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Study Product Adherence
Časové okno: Weeks 12 and 26
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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.
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Weeks 12 and 26
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in plasma cell-free mitochondrial DNA
Časové okno: Baseline, Week 12, and Week 26
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Change in plasma cell-free mitochondrial DNA concentration, measured as mitochondrial DNA copies per mL of plasma using droplet digital PCR.
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Baseline, Week 12, and Week 26
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Change in urine cell-free mitochondrial DNA
Časové okno: Baseline, Week 12, and Week 26
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Change in urine cell-free mitochondrial DNA concentration, measured using droplet digital PCR and reported as mitochondrial DNA copies normalized to urine osmolarity.
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Baseline, Week 12, and Week 26
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Change in skin fingernail capillary density
Časové okno: Baseline, Week 12, and Week 26
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Change in skin capillary density, measured as capillaries per mm2 using capillaroscopy.
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Baseline, Week 12, and Week 26
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Change in skin blood flow
Časové okno: Baseline, Week 12, and Week 26
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Change in skin blood flow, measured in laser Doppler perfusion units using laser Doppler flowmetry.
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Baseline, Week 12, and Week 26
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Change in six-minute walk distance
Časové okno: Baseline, Week 12, and Week 26
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Change in distance walked during the six-minute walk test, measured in meters.
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Baseline, Week 12, and Week 26
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Change in Handgrip Strength
Časové okno: Baseline, Week 12, and Week 26
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Change in handgrip strength, measured in kilograms using handheld dynamometry.
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Baseline, Week 12, and Week 26
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Change in Timed Up and Go
Časové okno: Baseline, Week 12, and Week 26
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Change in Timed Up and Go test performance, measured in seconds.
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Baseline, Week 12, and Week 26
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Change in 30-second sit-to-stand
Časové okno: Baseline, Week 12, and Week 26
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Change in the number of chair stands completed during the 30-second sit-to-stand test, measured as repetitions completed in 30 seconds.
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Baseline, Week 12, and Week 26
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Armin Ahmadi, PhD, University of California, San Diego
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Patologické procesy
- Mužská urogenitální onemocnění
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Chronické onemocnění
- Atributy nemoci
- Renální insuficience
- Patologické stavy, příznaky a symptomy
- Renální insuficience, chronická
- Farmaceutické přípravky
- Formy dávkování
- Tobolky
- Nicotinamid-beta-ribosid
Další identifikační čísla studie
- UCSD-NR-001
- 1K01DK147652 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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