Vitamin D3 Supplementation for Heart Failure Patients

Heidi Moretti, MS, RD

Status and phase: Completed; Phase 2

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

Treatments: Drug: Placebo Comparator: Sugar Pill; Drug: Vitamin D3 (cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT01636570

VitD3HF

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Vitamin D3 (cholecalciferol)

Active Comparator group

Description:

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

Treatment:

Drug: Vitamin D3 (cholecalciferol)

Sugar Pill

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Comparator: Sugar Pill