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Pilot Study of Vitamin D Supplementation in Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Liz, Fraser Health
ClinicalTrials.gov Identifier:
NCT01388855
First received: June 22, 2011
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to determine if the methods are feasible for a larger clinical trial.The study will examine the relationship between vitamin D status, quality of life, pain and walking distance of individuals living with heart failure.


Condition Intervention
Heart Failure
 Drug: Cholecalciferol
Drug: Placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Rate of participant recruitment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The percentage of patients recruited from those that present to clinic.

  • Rate of participant retention [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    The percentage of patients that remain enrolled in the study.

  • Rate of participant compliance with questionnaires, functional capacity measure and medication regimen. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    There will be two self-administered questionannaires. EQ-5D to measure quality of life and the brief pain inventory questionnaire to evaluate pain. Functional capacity will be measured by the standardized and validated 6 minute walk test. The percentage of those that participate in the 6 minute walk test will be reported.


Secondary Outcome Measures:
  • Number of participants with hypercalcemia as a measure of safety and tolerability. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Number of participants that achieve a target serum 25-hydroxyvitamin D of 75nmol/L [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • The values achieved for quality of life and pain questionnaire and functional capacity measure. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Quality of life will be measured by the EQ-5D questionnaire. Pain will be measured by the Brief Pain Inventory questionnaire. Functional capacity will be measured by the standardized and validated 6 minute walk test.


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol Drug: Cholecalciferol
Subjects receive cholecalciferol 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks.
Other Name: Vitamin D
Placebo Comparator: Placebo Drug: Placebo
Pills made to look like vitamin D but have no medication in them
Other Name: sugar pill

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 years of age or older
  • New York Heart Association functional Class II or III symptoms
  • Ability to communicate in English or through a translator
  • Competent to sign the informed consent

Exclusion Criteria:

  • Co-morbidity that would negatively impact quality of life (e.g. severe arthritis, or fibromyalgia)
  • Co-morbidity that would negatively impact vitamin D metabolism (glomerular filtration rate-15-29%, significant liver dysfunction
  • On a pharmaceutical agent that could lower Vitamin D levels (e.g. glucocorticoids, anticonvulsants)
  • Taking >600 IU vitamin D (cholecalciferol or ergocalciferol) daily
  • Moderate or severe cognitive impairment
  • Contraindication to vitamin D supplementation: history of hypercalcemia or conditions that increase the risk of hypercalcemia (sarcoidosis, tuberculosis or lymphoma)
  • Wheelchair bound (ambulation is a component of the QOL questionnaire
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388855

Locations
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Liz C da Silva, BHE Fraser Health
  More Information

No publications provided

Responsible Party: Liz, Clinical Resource Dietitian, Fraser Health
ClinicalTrials.gov Identifier: NCT01388855     History of Changes
Other Study ID Numbers: 2011-028
Study First Received: June 22, 2011
Last Updated: February 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by Fraser Health:
Heart Failure
Vitamin D
Pain
Pilot Study
RCT

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 May 16, 2013