A Trial of Vitamin D Therapy in Patients With Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2011 by University Hospitals Cleveland Medical Center.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT01125436

First received: May 17, 2010

Last updated: July 1, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 17, 2010
Last Updated Date	July 1, 2011
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 ] [ Designated as safety issue: No ] Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity Peak VO2 [ Time Frame: 6 months ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] strength of the proximal lower extremity muscles muscle strength [ Time Frame: 6 months ] [ Designated as safety issue: No ] 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 Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Arm (s)	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	Active, not recruiting
Estimated Enrollment ^ICMJE	64
Estimated 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
Gender	Both
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
Has Data Monitoring Committee	No
Plan to Share Data	Not Provided
IPD Description	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
Information Provided By	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

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