Status:
TERMINATED
Vitamin D Supplementation for Treatment of Heart Failure
Lead Sponsor:
University of Michigan
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Detailed Description
Primary Objective To determine how rapid vitamin D supplementation affects biomarkers and submaximal exercise capacity in systolic HF patients with low vitamin D status. Working Hypothesis 1: HF pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01230307
Start Date
October 1 2010
End Date
December 1 2014
Last Update
November 18 2016
Active Locations (1)
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1
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109