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Vitamin

Nicotinamide Riboside for Kidney Disease

Q: Is the enrollment window for this study still open?

This clinical study is actively searching for participants, based on the information published by clinicaltrials.gov. It was first advertised on November 19th 2019 with an update posted on January 6th 2022.

Q: Does Nicotinamide riboside present any safety risks to individuals?

The safety of Nicotinamide riboside, which is in Phase 2 development, was evaluated as a 2 on the scale due to preliminary evidence of its security but lack of data regarding efficacy.

Q: Are there prior records of testing Nicotinamide riboside's effectiveness?

Currently, 15 trials are being conducted to evaluate the efficacy of Nicotinamide riboside. Out of these studies, one is in Phase 3. <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>'s Winston-Salem houses a majority of these investigations but there are 19 sites across America running this clinical trial.

Q: Is this trial open to seniors beyond sixty years of age?

This clinical trial is restricted to participants aged 35-80. For those below 18 years of age, there are 53 trials available while 641 opportunities exist for seniors over 65.

Q: To what extent is the patient population involved in this medical experiment?

Affirmative. According to clinicaltrials.gov, this research initiative is currently recruiting participants. It was first posted on November 19th 2019 and its latest update occurred on January 6th 2022. A total of 118 people are needed from one site for the study's completion.

Q: Am I eligible to become a participant in this clinical trial?

This medical trial seeks 118 participants aged between 35 and 80 who have been classified with Chronic Kidney Disease (CKD) stage III or IV. Other eligibility criteria include a willingness to be randomly assigned, the ability to give informed consent, blood pressure below 140/90 mmHg in the last 3 months, body mass index less than 40 kg/m2, and no more than 2kg weight change within the same period of time.

Phase 2

Recruiting

Led By Michel Chonchol, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

CKD stage III or IV (eGFR with the 4-variable MDRD prediction equation: 20-60 mL/min/1.73m2; stable renal function in the past 3 months)

Weight stable in the prior 3 months (<2 kg weight change) and willing to remain weight stable throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Awards & highlights

Study Summary

This trial will test whether nicotinamide riboside, a precursor of NAD+, is safe and effective in reducing aortic stiffness and blood pressure in patients with stage III and IV CKD.

Who is the study for?

This trial is for adults aged 35-80 with moderate to severe chronic kidney disease (stages III or IV), who have had stable weight and blood pressure control. They must not be pregnant, planning pregnancy, or nursing, and should not have been hospitalized recently or taking certain immunosuppressants.Check my eligibility

What is being tested?

The trial tests if nicotinamide riboside supplements can reduce arterial stiffness and high systolic blood pressure in CKD patients. It's a phase IIa study where participants are randomly given either the supplement or a placebo twice daily for three months.See study design

What are the potential side effects?

Potential side effects of nicotinamide riboside may include nausea, fatigue, headaches, diarrhea, indigestion and other gastrointestinal discomforts. The safety profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is moderately to severely reduced but stable.

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My weight has been stable, with less than a 2 kg change, for the last 3 months.

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I am between 35 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

carotid-femoral pulse wave velocity

Secondary outcome measures

Systolic blood pressure

Other outcome measures

Change in blood cellular NAD+ metabolism

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v4.0

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotinamide RibosideExperimental Treatment1 Intervention

Each nicotinamide riboside capsule contains 250 mg of nicotinamide riboside chloride mixed with microcrystalline cellulose. Dosage: 500 mg by mouth twice a day for 3 months.

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo capsules.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide riboside

2021

Completed Phase 3

~400

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,474 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,408 Total Patients Enrolled

Michel Chonchol, MDPrincipal InvestigatorUniversity of Colorado, Denver

3 Previous Clinical Trials

290 Total Patients Enrolled

Media Library

Nicotinamide Riboside (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04040959 — Phase 2

Kidney Disease Research Study Groups: Nicotinamide Riboside, Placebo

Kidney Disease Clinical Trial 2023: Nicotinamide Riboside Highlights & Side Effects. Trial Name: NCT04040959 — Phase 2

Nicotinamide Riboside (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04040959 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment window for this study still open?

"This clinical study is actively searching for participants, based on the information published by clinicaltrials.gov. It was first advertised on November 19th 2019 with an update posted on January 6th 2022."

Answered by AI

Does Nicotinamide riboside present any safety risks to individuals?

"The safety of Nicotinamide riboside, which is in Phase 2 development, was evaluated as a 2 on the scale due to preliminary evidence of its security but lack of data regarding efficacy."

Answered by AI

Are there prior records of testing Nicotinamide riboside's effectiveness?

"Currently, 15 trials are being conducted to evaluate the efficacy of Nicotinamide riboside. Out of these studies, one is in Phase 3. North carolina's Winston-Salem houses a majority of these investigations but there are 19 sites across America running this clinical trial."

Answered by AI

Is this trial open to seniors beyond sixty years of age?

"This clinical trial is restricted to participants aged 35-80. For those below 18 years of age, there are 53 trials available while 641 opportunities exist for seniors over 65."

Answered by AI

To what extent is the patient population involved in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this research initiative is currently recruiting participants. It was first posted on November 19th 2019 and its latest update occurred on January 6th 2022. A total of 118 people are needed from one site for the study's completion."

Answered by AI

Am I eligible to become a participant in this clinical trial?

"This medical trial seeks 118 participants aged between 35 and 80 who have been classified with Chronic Kidney Disease (CKD) stage III or IV. Other eligibility criteria include a willingness to be randomly assigned, the ability to give informed consent, blood pressure below 140/90 mmHg in the last 3 months, body mass index less than 40 kg/m2, and no more than 2kg weight change within the same period of time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD

2019. "Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04040959.

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