A Trial of Vitamin D Therapy in Patients With Heart Failure

Tracking Information
First Submitted Date ICMJE	May 17, 2010
First Posted Date ICMJE	May 18, 2010
Last Update Posted Date	July 4, 2011
Study Start Date ICMJE	July 2008
Estimated Primary Completion Date	September 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 17, 2010)	Peak VO2 [ Time Frame: baseline ]Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity; Peak VO2 [ Time Frame: 6 months ]Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01125436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 17, 2010)	muscle strength [ Time Frame: baseline ]strength of the proximal lower extremity muscles; muscle strength [ Time Frame: 6 months ]strength of the proximal lower extremity muscles
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Trial of Vitamin D Therapy in Patients With Heart Failure
Official Title ICMJE	A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
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	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Heart Failure; Aerobic Capacity; Strength
Intervention ICMJE	Dietary Supplement: Cholecalciferol 50,000 IU weekly for 6 months Other Name: Vitamin D; Dietary Supplement: Cholecalciferol Placebo weekly for 6 months
Study Arms	Experimental: Cholecalciferol Nutritional supplement Intervention: Dietary Supplement: Cholecalciferol; Placebo Comparator: placebo Intervention: Dietary Supplement: Cholecalciferol
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: May 17, 2010)	64
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 2011
Estimated Primary Completion Date	September 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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,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
Sex/Gender	Sexes Eligible for Study: All
Ages	50 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01125436
Other Study ID Numbers ICMJE	1KL2RR024990( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Rebecca S. Boxer, MD, Case Western Reserve University
Study Sponsor ICMJE	University Hospitals Cleveland Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	University Hospitals Cleveland Medical Center
Verification Date	July 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP