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Vitamin D Supplementation for Treatment of Heart Failure

NCT01230307 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-11-18

Study results available
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Summary

The central objective of this proposal is to establish that vitamin D supplementation in heart failure patients with low vitamin D levels will have improved outcomes compared to placebo. In addition the investigators will also evaluate the role of genetics in regard to vitamin D and heart failure. The investigators will be evaluating what is currently a novel approach of identifying patients with low vitamin D and treating this low vitamin D level. The investigators will be able to evaluate the importance of vitamin D supplementation in these patients and the role of genetics on our defined outcomes.

Conditions

Interventions

DRUG

Vitamin D3

Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months

DRUG

Placebo

A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.

Sponsors & Collaborators

Principal Investigators

  • Barry E. Bleske, Pharm. D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230307 on ClinicalTrials.gov