Vitamin D Supplementation for Treatment of Heart Failure (DELIGHTFUL)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014