Vitamin D3 Supplementation for Heart Failure Patients

NCT01636570 | Completed Phase 2 DMC

• 1 other identifier: VitD3HF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if treatment with vitamin D3 of 10,000 International Units (IU) daily in vitamin D deficient patients for 6 months will improve B type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in patients with stable congestive heart failure (Class II or III).

Conditions

Heart Failure; Vitamin D Deficiency; Cardiomyopathy; Congestive Heart Failure

Keywords

Vitamin D; Cholecalciferol; Heart Failure; Congestive heart failure; Cardiomyopathy; Strength; Parathyroid Hormone; Calcium; Quality of Life; C reactive protein; Cardiopulmonary exercise testing; Prognosis

Outcome Measures

Primary Outcomes (1)

• B type Natriuretic Peptide (BNP)

  BNP is a hormone secreted by the heart ventricles, and high concentrations of this hormone occur in heart failure. It is a strong prognostic indicator.

  Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo

Secondary Outcomes (6)

• Cardiopulmonary exercise test (CPX)

  Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo

• 25 hydroxyvitamin D [25 (OH)D]

  Change in 25 hydroxyvitamin D will be measured at baseline, at 12 weeks, and after 6 months of treatment with vitamin D or placebo

• C reactive protein (CRP)

  Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo

• Serum Calcium

  Change in serum calcium levels will be measured at baseline, at 12 weeks, and at 6 months of treatment with vitamin D or placebo

• 6 minute walk test

  Change in the 6 minute walk test will be measured at baseline and at 6 months of treatment with vitamin D or placebo

Study Arms (2)

Vitamin D3 (cholecalciferol)

ACTIVE COMPARATOR

10,000 International Units of vitamin D3 will be given daily for 6 months in vitamin D deficient heart failure patients.

Drug: Vitamin D3 (cholecalciferol)

Sugar Pill

PLACEBO COMPARATOR

Patients will be given an placebo that is identical in appearance to the active comparator. It will be given as 2 gelcaps per day.

Drug: Placebo Comparator: Sugar Pill

Interventions

Placebo Comparator: Sugar Pill DRUG

Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.

Also known as: Bio-tech Pharmacal

Sugar Pill

Vitamin D3 (cholecalciferol) DRUG

10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.

Also known as: Bio-tech Pharmacal

Vitamin D3 (cholecalciferol)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA Heart Failure Class II or II, stable
• Vitamin D deficiency (32 ng/ml or less)
• No recent medication changes for 3 months
• Females of childbearing age must use effective contraceptive if they are sexually active

You may not qualify if:

• Hypercalcemia
• Nephrolithiases
• Sarcoidosis
• Acute cardiac insufficiency
• Pregnancy
• Breastfeeding
• Any clinically unstable medical condition
• Supplements of greater than or equal to 1000 units of vitamin D per day

Sponsors & Collaborators

• Heidi Moretti, MS, RD: lead
• Saint Patrick Hospital: collaborator

Study Sites (2)

International Heart Institute of Montana

Missoula, Montana, 59802, United States

Location

Saint Patrick Hosptial

Missoula, Montana, 59802, United States

Location

Related Publications (1)

• Moretti HD, Colucci VJ, Berry BD. Vitamin D3 repletion versus placebo as adjunctive treatment of heart failure patient quality of life and hormonal indices: a randomized, double-blind, placebo-controlled trial. BMC Cardiovasc Disord. 2017 Oct 30;17(1):274. doi: 10.1186/s12872-017-0707-y.

  PMID: 29084522 DERIVED

MeSH Terms

Conditions

Heart Failure; Vitamin D Deficiency; Cardiomyopathies

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bradley D Berry, MD

  International Heart Institute of Montana

  PRINCIPAL INVESTIGATOR

• Heidi D Moretti, MS, RD

  Saint Patrick Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 10, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)