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Vitamin D Supplementation for Treatment of Heart Failure (DELIGHTFUL)

This study has been terminated.
(Unable to recruit sufficient number of patients.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01230307
First Posted: October 29, 2010
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Barry E. Bleske, University of Michigan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: D suppLementation In HearT FaiLure (DELIGHTFUL)

Resource links provided by NLM:


Further study details as provided by Barry E. Bleske, University of Michigan:

Primary Outcome Measures:
  • Biomarkers [ Time Frame: 6 months ]
    Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).


Secondary Outcome Measures:
  • Exercise Capacity Measured by 6 Minute Walk Test [ Time Frame: 6 months ]
  • Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire [ Time Frame: 6 months ]
    Kansas City Cardiomyopathy Questionnaire for quality of life is measured on a scale of 0 - 100, with 100 being best.

  • Vitamin D Genomics [ Time Frame: Baseline ]
    Genotyped for the restricted fragment length polymorphism at the BsmI site. In addition CYP2R1, CYP27B1, CYP24 will also be genotyped.


Enrollment: 28
Study Start Date: October 2010
Study Completion Date: December 2014
Primary Completion Date: December 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.
Other Name: Sugar Pill

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 patients when supplemented with vitamin D for 6 months will have lower measures of inflammation and extracellular-matrix remodeling compared with placebo.

Working Hypothesis 2: HF patients when supplemented with vitamin D for 6 months will have longer 6-minute walk length compared with placebo.

Secondary Objectives To establish a relationship between the CYP2R1 variant and surrogate markers in systolic HF patients.

Working Hypothesis 3: HF patients with the CYP2R1 G allele will have higher measures of inflammation and extracellular-matrix remodeling compared to AA subjects. This relationship will also be seen in subjects with the CYP2R1 TagSNP variants.

Working Hypothesis 4: HF patients with CYP2R1 variant alleles will have shorter 6-minute walk length compared to subjects without these variants.

To genotype HF subjects for the VDR variants and additional tag SNPs, to ascertain the relationship between VDR genetic variation and surrogate markers in systolic HF patients.

Working Hypothesis 5: HF patients with VDR variants will have greater measures of inflammation and extracellular-matrix remodeling compared to subjects without VDR variants.

Working Hypothesis 6: HF patients with VDR variants will have a shorter 6-minute walk length compared to subjects without these variants.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230307


Locations
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Barry E. Bleske, Pharm. D. University of Michigan
  More Information

Responsible Party: Barry E. Bleske, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01230307     History of Changes
Other Study ID Numbers: VitD3
First Submitted: October 27, 2010
First Posted: October 29, 2010
Results First Submitted: September 28, 2016
Results First Posted: November 18, 2016
Last Update Posted: November 18, 2016
Last Verified: September 2016

Keywords provided by Barry E. Bleske, 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
Bone Density Conservation Agents