Vitamin D Supplementation for Treatment of Heart Failure

Heart Failure Clinical Trial

— DELIGHTFUL  

Official title:

D suppLementation In HearT FaiLure (DELIGHTFUL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01230307
• Other study ID #: VitD3
• Status: Terminated
• Phase: Phase 4
• First received: October 27, 2010
• Last updated: December 30, 2014
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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
• Placebo
A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers		6 months	No
Secondary	Exercise capacity		6 months	No
Secondary	Quality of Life		6 months	No
Secondary	Vitamin D genomics		Baseline	No