Vitamin D Supplementation for Treatment of Heart Failure

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01230307

Run by

University of Michigan

People needed

28

Starts

2010-10-01

Expected to finish

2014-12-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HF patients with LV systolic dysfunction of ischemic or non-ischemic origin and an LVEF <40% using nuclear ventriculography or echocardiography within the last 6 months.
• Attempts should have been made at optimizing medical therapy and the participant should be stable on these medications for at least 3 months.
• Patients with a 25(OH)D level between 10-25 ng/ml

You may not qualify if…

• Inability to give informed consent
• Patients with sarcoidosis or other granulomatous disease that can alter vitamin D metabolism
• Patients with primary valvular HF, hypertrophic cardiomyopathy, and drug-induced HF
• Renal dysfunction defined as serum creatinine > 2.5 mg/dl
• Pregnant women
• Patients <18 years of age
• Patients on vitamin D supplementation

Where it is running

• University of Michigan Medical Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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