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A Trial of Vitamin D Therapy in Patients With Heart Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
May 17, 2010
July 1, 2011
July 2008
September 2011   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01125436 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Aerobic Capacity
  • Strength
  • Dietary Supplement: Cholecalciferol
    50,000 IU weekly for 6 months
    Other Name: Vitamin D
  • Dietary Supplement: Cholecalciferol
    Placebo weekly for 6 months
  • Experimental: Cholecalciferol
    Nutritional supplement
    Intervention: Dietary Supplement: Cholecalciferol
  • Placebo Comparator: placebo
    Intervention: Dietary Supplement: Cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
64
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01125436
1KL2RR024990
No
Not Provided
Not Provided
Not Provided
Rebecca S. Boxer, MD, Case Western Reserve University
University Hospitals Cleveland Medical Center
Not Provided
Not Provided
University Hospitals Cleveland Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP