Pilot Study of Vitamin D Supplementation in Heart Failure

A Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin D in Heart Failure: A Pilot Study

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: 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
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Royal Columbian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of participant recruitment	The percentage of patients recruited from those that present to clinic.	6 months
Participant compliance with study procedures	Proportion completing the quality of life questionnaire, 6 minute walk test and medication regimen	6 months
Participant rate of retention	Proportion of participants retained in study	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fraser Health
• Investigators: Principal Investigator: Liz C da Silva, MS, Fraser Health Authority

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 18, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Heart Failure; Vitamin D; Pain; RCT; Pilot Study
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2011-028