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 Hospital Case Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01125436
First received: May 17, 2010
Last updated: July 1, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention
Heart Failure
Aerobic Capacity
Strength
Dietary Supplement: Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 64
Study Start Date: July 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125436

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

No publications provided

Responsible Party: Rebecca S. Boxer, MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01125436     History of Changes
Other Study ID Numbers: 1KL2RR024990
Study First Received: May 17, 2010
Last Updated: July 1, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014