Text Size

A Trial of Vitamin D Therapy in Patients With Heart Failure

This study is ongoing, but not recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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
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 June 17, 2013