Heart Failure
Conditions
Keywords
Aerobic Capacity, Strength
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.
Interventions
DIETARY_SUPPLEMENTCholecalciferol
50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak VO2 | change from baseline to 6 months | Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum Aldosterone | change from baseline to 6 months | Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. |
| Plasma Renin Activity | change in renin from baseline to 6 months | Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. |
Countries
United States
Participant flow
Recruitment details
recruitment May 2007-April 2011 outpatient heart failure and cardiology clinics
Participants by arm
| Arm | Count |
|---|---|
| Cholecalciferol + Calcium Participants received vitamin D | 31 |
| Placebo + Calcium Participants received placebo | 33 |
| Total | 64 |
Baseline characteristics
| Characteristic | Cholecalciferol + Calcium | Placebo + Calcium | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 10.6 | 66.0 years STANDARD_DEVIATION 10.4 | 65.9 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 31 participants | 33 participants | 64 participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 15 Participants | 18 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 3 / 31 | 0 / 33 |
Outcome results
Primary
Peak VO2
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
Time frame: change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cholecalciferol + Calcium | Peak VO2 | -.17 ml/kg/min | Standard Deviation 2.07 |
| Placebo +Calcium | Peak VO2 | -.68 ml/kg/min | Standard Deviation 1.85 |
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).
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cholecalciferol + Calcium | 6 Minute Walk Distance | 59 meters | Standard Deviation 282 |
| Placebo +Calcium | 6 Minute Walk Distance | 36 meters | Standard Deviation 228 |
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
Time frame: change from baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cholecalciferol + Calcium | Leg Proximal Muscle Strength | Flexion 60°s-1 | 1.6 newton-meters/kg | Standard Deviation 17.2 |
| Cholecalciferol + Calcium | Leg Proximal Muscle Strength | Extension 60°s-1 | 5.2 newton-meters/kg | Standard Deviation 29.7 |
| Placebo +Calcium | Leg Proximal Muscle Strength | Flexion 60°s-1 | 5.1 newton-meters/kg | Standard Deviation 8.8 |
| Placebo +Calcium | Leg Proximal Muscle Strength | Extension 60°s-1 | 3.5 newton-meters/kg | Standard Deviation 17.1 |
Secondary
Timed Get Up and Go
stand from chair walk 3 meters, return to chair and sit
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cholecalciferol + Calcium | Timed Get Up and Go | -0.2 seconds | Standard Deviation 3.3 |
| Placebo +Calcium | Timed Get Up and Go | -1.0 seconds | Standard Deviation 3.3 |
Other Pre-specified
Plasma Renin Activity
Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.
Time frame: change in renin from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cholecalciferol + Calcium | Plasma Renin Activity | 1.3 ng/ml/hr | Standard Deviation 13.84 |
| Placebo +Calcium | Plasma Renin Activity | -2.5 ng/ml/hr | Standard Deviation 15.25 |
Other Pre-specified
Serum Aldosterone
Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.
Time frame: change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cholecalciferol + Calcium | Serum Aldosterone | 3.7 ng/dl | Standard Deviation 13.65 |
| Placebo +Calcium | Serum Aldosterone | -0.1 ng/dl | Standard Deviation 15.55 |