Overview

This trial is active, not recruiting.

Conditions heart failure, aerobic capacity, strength
Treatments cholecalciferol
Sponsor University Hospital Case Medical Center
Start date July 2008
End date September 2011
Trial size 64 participants
Trial identifier NCT01125436, 1KL2RR024990

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Nutritional supplement
cholecalciferol Vitamin D
50,000 IU weekly for 6 months
(Placebo Comparator)
cholecalciferol
Placebo weekly for 6 months

Primary Outcomes

Measure
Peak VO2
time frame: baseline
Peak VO2
time frame: 6 months

Secondary Outcomes

Measure
muscle strength
time frame: baseline
muscle strength
time frame: 6 months

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - 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,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

Additional Information

Official title A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by University Hospital Case Medical Center.