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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Armin Ahmadi, PhD
- 電話番号：619-543-6248
- メール：a3ahmadi@ucsd.edu
研究連絡先のバックアップ
- 名前：Rakesh Malhotra, MD, MPH
- メール：r3malhotra@health.ucsd.edu
研究場所
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California
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San Diego、California、アメリカ、92093
- Altman Clinical and Translation Research Institute
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コンタクト：
- Armin Ahmadi, PhD
- 電話番号：(619) 543-6248
- メール：a3ahmadi@ucsd.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in plasma cell-free mitochondrial DNA
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in skin fingernail capillary density
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Armin Ahmadi, PhD、University of California, San Diego
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UCSD-NR-001
- 1K01DK147652 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
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