Vitamin D Supplementation for Treatment of Heart Failure (DELIGHTFUL)

This study is currently recruiting participants.
Verified March 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Barry E. Bleske, University of Michigan
ClinicalTrials.gov Identifier:
NCT01230307
First received: October 27, 2010
Last updated: December 9, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Vitamin D3
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: D suppLementation In HearT FaiLure (DELIGHTFUL)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Vitamin D genomics [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
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: 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
Other Name: cholecalciferol
Placebo Comparator: Placebo
A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
Drug: Placebo
A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230307

Contacts
Contact: Barry E Bleske, Pharm. D 734-764-5341 bbleske@umich.edu

Locations
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Sub-Investigator: Michael P. Dorsch, Pharm. D.         
Sub-Investigator: Keith Aaronson, MD         
Sub-Investigator: Robert Simpson, Ph.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Barry E. Bleske, Pharm. D. University of Michigan
  More Information

No publications provided

Responsible Party: Barry E. Bleske, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01230307     History of Changes
Other Study ID Numbers: VitD3
Study First Received: October 27, 2010
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Michigan:
Vitamin D
Systolic failure
Genomics
Biomarkers
Exercise
Quality of Life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014