Pilot Study of Vitamin D Supplementation in Heart Failure
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.
|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|
- 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
- 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.
|Study Start Date:||September 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Patients were given two cholecalciferol tablets (10,000 IU each) daily for 30 days.
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.
Pills made to look like vitamin D but have no medication in them
Other Name: sugar pill
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388855
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Principal Investigator:||Liz C da Silva, MS||Fraser Health Authority|