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Pilot Study of Vitamin D Supplementation in Heart Failure

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ClinicalTrials.gov Identifier: NCT01388855
Recruitment Status : Completed
First Posted : July 7, 2011
Last Update Posted : June 19, 2015
Information provided by (Responsible Party):
Liz, Fraser Health

Brief Summary:
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 or disease Intervention/treatment
Heart Failure Drug: Cholecalciferol Drug: Placebo

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%.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin D in Heart Failure: A Pilot Study
Study Start Date : September 2011
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate of participant recruitment [ Time Frame: 6 months ]
    The percentage of patients recruited from those that present to clinic.

  2. Participant compliance with study procedures [ Time Frame: 6 months ]
    Proportion completing the quality of life questionnaire, 6 minute walk test and medication regimen

  3. Participant rate of retention [ Time Frame: 6 months ]
    Proportion of participants retained in study

Secondary Outcome Measures :
  1. Number of participants with hypercalcemia as a measure of safety and tolerability. [ Time Frame: 6 months ]
  2. Number of participants that achieve a target serum 25-hydroxyvitamin D of 75nmol/L [ Time Frame: 8 months ]
  3. The values achieved for quality of life and pain questionnaire and functional capacity measure. [ Time Frame: 8 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388855

Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Fraser Health
Principal Investigator: Liz C da Silva, MS Fraser Health Authority

Responsible Party: Liz, Clinical Resource Dietitian, Fraser Health
ClinicalTrials.gov Identifier: NCT01388855     History of Changes
Other Study ID Numbers: 2011-028
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by Liz, Fraser Health:
Heart Failure
Vitamin D
Pilot Study

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents