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

Launched by UNIVERSITY OF COLORADO, DENVER · Jul 30, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called nicotinamide riboside on patients with moderate to severe chronic kidney disease (CKD). The goal is to see if this supplement can help reduce arterial stiffness and lower high blood pressure, which are important factors in preventing heart diseases. The trial will involve participants aged 35 to 80 who have stable kidney function and controlled blood pressure. To qualify, individuals should not be undergoing dialysis, have certain serious health conditions, or be pregnant.

Participants in the trial will take either the nicotinamide riboside supplement or a placebo (a non-active pill) for three months while being monitored for changes in their arterial stiffness and blood pressure. The study will also check for any side effects to ensure safety. This research is important because it could lead to new ways to improve heart health in people with CKD without needing strict diet changes that are often hard to maintain. If you're interested in participating, it’s a chance to contribute to important medical research that could benefit many others with similar health challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 35-80 years;
• • Ability to provide informed consent;
• • Willing to accept random assignment to condition;
• • 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);
• • Blood pressure controlled to \<140/90 mmHg for the past 3 months;
• • Body mass index \<40 kg/m2;
• • Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study
• Exclusion Criteria:
• • Patients with advanced CKD requiring chronic dialysis;
• • Significant co-morbid conditions that lead the investigator to conclude that life expectancy \< 1 year;
• • History of severe congestive heart failure (i.e., ejection fraction \< 35%);
• • Hospitalization in the past month;
• • Proteinuria \> 5 g/day;
• • Immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months;
• • Known malignancy;
• • Woman who are pregnant, nursing or planning to become pregnant;
• • Special classes of subjects considered vulnerable populations will not be included in the study.