Vitamin D Supplementation for Treatment of Heart Failure

NCT01230307 | Terminated Phase 4 Results

• 1 other identifier: VitD3
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

Vitamin D; Systolic failure; Genomics; Biomarkers; Exercise; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Biomarkers

  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).

  6 months

Secondary Outcomes (3)

• Exercise Capacity Measured by 6 Minute Walk Test

  6 months

• Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire

  6 months

• Vitamin D Genomics

  Baseline

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vitamin D3 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

Also known as: cholecalciferol

Vitamin D

Placebo DRUG

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

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Cholecalciferol; Sugars

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Carbohydrates

Limitations and Caveats

Only a fraction of the original goal of enrollment was met. Therefore, analysis of comparative results was not done. No conclusions of any kind can be made from analyzing the data with the number of patients completing the trial (6 vs 4 patients).

Results Point of Contact

• Title: Barry Bleske
• Organization: University of Michigan

bbleske@umich.edu

734-763-3232

Study Officials

• Barry E. Bleske, Pharm. D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 18, 2016
• Results First Posted: November 18, 2016

Record last verified: 2016-09

Locations

US (1)