A Trial of Vitamin D Therapy in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125436
• Other study ID #: 1KL2RR024990
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: September 2011

Study information

• Verified date: July 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Cholecalciferol
50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily
• Cholecalciferol
Weekly placebo plus 800 calcium alone

Locations

Country	Name	City	State
United States	University Hospitals/Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Aldosterone	Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.	change from baseline to 6 months
Other	Plasma Renin Activity	Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.	change in renin from baseline to 6 months
Primary	Peak VO2	Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity	change from baseline to 6 months
Secondary	Leg Proximal Muscle Strength	Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension	change from baseline to 6 months
Secondary	6 Minute Walk Distance	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).	Change from baseline to 6 months
Secondary	Timed Get Up and Go	stand from chair walk 3 meters, return to chair and sit	Change from baseline to 6 months