N/A
Completed N=64
A Trial of Vitamin D Therapy in Patients With Heart Failure
Source: ClinicalTrials.gov NCT01125436 ↗Enrolled (actual)
64
Serious AEs
4.7%
Results posted
Aug 2022
Primary outcomePrimary: Peak VO2 — -.17; -.68 ml/kg/min
Summary
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak VO2 |
-.17; -.68 | — |
| SECONDARY Leg Proximal Muscle Strength |
1.6; 5.1; 5.2; 3.5 | — |
| SECONDARY 6 Minute Walk Distance |
59; 36 | — |
| SECONDARY Timed Get Up and Go |
-0.2; -1.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01125436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.