A Trial of Vitamin D Therapy in Patients With Heart Failure
A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
1 other identifier
interventional
64
1 country
1
Brief Summary
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jul 2008
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
August 10, 2022
CompletedAugust 10, 2022
July 1, 2022
3.2 years
May 17, 2010
March 13, 2022
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak VO2
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
change from baseline to 6 months
Secondary Outcomes (3)
Leg Proximal Muscle Strength
change from baseline to 6 months
6 Minute Walk Distance
Change from baseline to 6 months
Timed Get Up and Go
Change from baseline to 6 months
Other Outcomes (2)
Serum Aldosterone
change from baseline to 6 months
Plasma Renin Activity
change in renin from baseline to 6 months
Study Arms (2)
Cholecalciferol
EXPERIMENTALNutritional supplement
placebo
PLACEBO COMPARATORWeekly placebo plus 800 calcium daily
Interventions
50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals/Case Medical Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Compliance Officer
- Organization
- Case Western Reserve University
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Boxer, MD
Case Western Reserve Univerity
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 18, 2010
Study Start
July 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
August 10, 2022
Results First Posted
August 10, 2022
Record last verified: 2022-07