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

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ClinicalTrials.gov Identifier: NCT02701127
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ali Poyan Mehr, 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Oral niacinamide, 1 gram daily Drug: Oral niacinamide, 3 gram daily Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Niacinamide 1 gram
Oral niacinamide, 1 gram daily
Drug: Oral niacinamide, 1 gram daily
Active Comparator: Niacinamide 3 grams
Oral niacinamide, 3 grams daily
Drug: Oral niacinamide, 3 gram daily
Placebo Comparator: Placebo
Oral placebo pill
Drug: Placebo



Primary Outcome Measures :
  1. Changes from baseline in serum metabolite profile of niacinamide [ Time Frame: Baseline and days 1 through 4 ]

Secondary Outcome Measures :
  1. Changes from baseline in urine metabolite profile of niacinamide [ Time Frame: Baseline and days 1 through 4 ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: From enrollment through day 4, and at day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass at high risk for acute kidney injury. A Cleveland score of 6 or more is used to define patients at high risk for acute kidney injury
  2. Age ≥ 18
  3. Signed informed consent

Exclusion criteria

  1. Pre-existing acute kidney injury
  2. Kidney transplantation
  3. Off-pump heart surgery
  4. Pregnancy
  5. End stage renal disease
  6. Pregnancy (female subjects of childbearing potential must have a negative serum pregnancy test)
  7. Subjects with any kind of dependency on the investigator (e.g. any subject who is under direct supervision of the investigator/co-investigators or employed by the investigator/co-investigators) 8 Subjects held in an institution by legal or official order (e.g. subjects in jail, prison, juvenile offender facility, or treatment facility including those who are in hospitals, alcohol, and drug treatment facilities under court order, and individuals with psychiatric illnesses who have been committed involuntarily to an institution)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701127


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Ali Poyan Mehr, Instructor in Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02701127    
Other Study ID Numbers: 2016P000028
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents