Pilot Study of Vitamin D Supplementation in Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Fraser Health.
Recruitment status was  Active, not recruiting
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
  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:


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
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: 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 July 22, 2014