Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury

Early Phase 1

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Oral niacinamide, 3 gram daily; Drug: Placebo; Drug: Oral niacinamide, 1 gram daily

• Registration Number: NCT02701127
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

This is a single center, randomized, single-blind, placebo-controlled study to evaluate the safety and biochemical effects of niacinamide on metabolic parameters of the kidney in patients undergoing cardiac surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-29
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Primary Completion: 2017-02
• Study Completion: 2017-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niacinamide 3 grams	Oral niacinamide, 3 gram daily	Oral niacinamide, 3 grams daily
Placebo	Placebo	Oral placebo pill
Niacinamide 1 gram	Oral niacinamide, 1 gram daily	Oral niacinamide, 1 gram daily

Primary Outcome Measures

Name	Time	Method
Changes from baseline in serum metabolite profile of niacinamide	Baseline and days 1 through 4

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in urine metabolite profile of niacinamide	Baseline and days 1 through 4

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States