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Vitamin D Supplementation for Treatment of Heart Failure

NCT ID: NCT01230307

Last Updated: 2016-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Keywords

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Vitamin D Systolic failure Genomics Biomarkers Exercise Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

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 two placebo tablets daily for 6 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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cholecalciferol Sugar Pill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Barry E. Bleske

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry E. Bleske, Pharm. D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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VitD3

Identifier Type: -

Identifier Source: org_study_id