A Trial of Vitamin D Therapy in Patients With Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Cholecalciferol

• Registration Number: NCT01125436
• Lead Sponsor: Case Western Reserve University

Brief Summary

The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.

Detailed Description

The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.

A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients \> 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2022-03-13
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Results First Posted: 2022-08-10
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• New York Heart Association (NYHA) class II-IV
• Able to walk
• Serum 25OHD level 37.5 ng/ml or less
• Fully titrated on heart failure medications

Exclusion Criteria

• Osteoporosis
• Primary hyperparathyroidism or hypercalcemia.
• Nephrolithiasis
• Hemo or peritoneal dialysis and/or creatinine of > 2.5
• Current use of daily vitamin D greater than 400 IU, corticosteroids, parathyroid hormone (PTH), androgen or estrogen
• Current illicit drug user or > 3 alcoholic drinks a day
• Metastatic or advanced cancer
• Myocardial infarction in the preceding 6 months
• Medications which can lower vitamin D levels or bioavailability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol	Cholecalciferol	Nutritional supplement
placebo	Cholecalciferol	Weekly placebo plus 800 calcium daily

Primary Outcome Measures

Name	Time	Method
Peak VO2	change from baseline to 6 months	Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity

Secondary Outcome Measures

Name	Time	Method
Leg Proximal Muscle Strength	change from baseline to 6 months	Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension
6 Minute Walk Distance	Change from baseline to 6 months	The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL).
Timed Get Up and Go	Change from baseline to 6 months	stand from chair walk 3 meters, return to chair and sit

Trial Locations

Locations (1)

University Hospitals/Case Medical Center; 🇺🇸 Cleveland, Ohio, United States