Heart Failure Clinical Trial
Official title:
A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
NCT number | NCT01125436 |
Other study ID # | 1KL2RR024990 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2008 |
Est. completion date | September 2011 |
Verified date | July 2022 |
Source | Case Western Reserve University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals/Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University |
United States,
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 |
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