Trial | NCT01636570  Report issue

Title

Vitamin D3 Supplementation for Heart Failure Patients
Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    40
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).
Study Started
Aug 31
2012
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Apr 26
2017

Drug Placebo Comparator: Sugar Pill

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

  • Other names: Bio-tech Pharmacal

Drug Vitamin D3 (cholecalciferol)

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

  • Other names: Bio-tech Pharmacal

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.

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.

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted