Pilot Study of Vitamin D Supplementation in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Liz, Fraser Health
ClinicalTrials.gov Identifier:
NCT01388855
First received: June 22, 2011
Last updated: June 18, 2015
Last verified: June 2015
  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.

  • Participant compliance with study procedures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion completing the quality of life questionnaire, 6 minute walk test and medication regimen

  • Participant rate of retention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of participants retained in study


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.


Enrollment: 13
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol
Patients were given two cholecalciferol tablets (10,000 IU each) daily for 30 days.
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
Patients were given two cholecalciferol placebo tablets daily for 30 days.
Drug: Placebo
Pills made to look like vitamin D but have no medication in them
Other Name: sugar pill

Detailed Description:

This study is being conducted as a pilot project to determine the feasibility of the methods to inform the conduct of a future larger study. This double-blind randomized controlled trial will examine the relationship between vitamin D status, Quality of Life (QOL), pain and functional capacity of individuals living with heart failure (HF) pre and post vitamin D supplementation. The study outcome measures include: the rate of recruitment, retention and compliance with the study procedures. Quality of life will be measured by the EQ-5D™ questionnaire; the Brief Pain Inventory (BPI) will be used to evaluate subject pain. The 6-minute walk test (6MWT) will evaluate functional capacity. Serum 25-hydroxyvitamin D (25OHD) levels will quantify the adequacy of vitamin D dosing to achieve target 25OHD levels.

A convenience sample of 40 subjects (20 per treatment group) will be prospectively recruited from the Royal Columbian Hospital (RCH) Heart Function (HFx) Clinic. Subjects will be randomized to receive either vitamin D3 (cholecalciferol) or a matching placebo at a dose of 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks. Subjects will have their 25OHD levels measured, self-administer the EQ-5D™ and BPI questionnaires and perform the 6MWT at the study entry and again at the completion of the study (12 weeks after entry).

Descriptive statistics (mean, standard deviation and proportion as appropriate) will be used to describe the data. The feasibility of all study procedures will be reported by percentage and compared to the standard set by the team of 80%.

  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, MS Fraser Health Authority
  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: June 18, 2015
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 30, 2015