ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Vitamin D Therapy in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01125436
Recruitment Status : Unknown
Verified July 2011 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2010
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:
University Hospitals Cleveland Medical Center

Brief Summary:
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Aerobic Capacity Strength Dietary Supplement: Cholecalciferol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
Study Start Date : July 2008
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cholecalciferol
Nutritional supplement
Dietary Supplement: Cholecalciferol
50,000 IU weekly for 6 months
Other Name: Vitamin D
Placebo Comparator: placebo Dietary Supplement: Cholecalciferol
Placebo weekly for 6 months



Primary Outcome Measures :
  1. Peak VO2 [ Time Frame: baseline ]
    Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity

  2. Peak VO2 [ Time Frame: 6 months ]
    Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity


Secondary Outcome Measures :
  1. muscle strength [ Time Frame: baseline ]
    strength of the proximal lower extremity muscles

  2. muscle strength [ Time Frame: 6 months ]
    strength of the proximal lower extremity muscles



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125436


Locations
United States, Ohio
University Hospitals/Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center

Responsible Party: Rebecca S. Boxer, MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01125436     History of Changes
Other Study ID Numbers: 1KL2RR024990 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents