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.
- 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.
- 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|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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||
Pills made to look like vitamin D but have no medication in them
Other Name: sugar pill
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Principal Investigator:||Liz C da Silva, BHE||Fraser Health|