Clinical trial NCT01636570: Vitamin D3 Supplementation for Heart Failure Patients
Official title: Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Saint Patrick Hospital
Sponsor class: OTHER
Collaborators: name: Saint Patrick Hospital
First posted: 2012-07-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: B type Natriuretic Peptide (BNP)
timeFrame: Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo
Secondary outcomes:
measure: Cardiopulmonary exercise test (CPX)
timeFrame: Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo
measure: 25 hydroxyvitamin D [25 (OH)D]
timeFrame: Change in 25 hydroxyvitamin D will be measured at baseline, at 12 weeks, and after 6 months of treatment with vitamin D or placebo
measure: C reactive protein (CRP)
timeFrame: Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo
measure: Serum Calcium
timeFrame: Change in serum calcium levels will be measured at baseline, at 12 weeks, and at 6 months of treatment with vitamin D or placebo
measure: 6 minute walk test
timeFrame: Change in the 6 minute walk test will be measured at baseline and at 6 months of treatment with vitamin D or placebo
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo
Other outcomes:
Locations:
city: Missoula
country: United States
facility: International Heart Institute of Montana
state: Montana
city: Missoula
country: United States
facility: Saint Patrick Hosptial
state: Montana
Study officials:
affiliation: International Heart Institute of Montana
name: Bradley D Berry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Patrick Hospital
name: Heidi D Moretti, MS, RD
role: STUDY_DIRECTOR
References:
citation: 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.