Pilot Study of Vitamin D Supplementation in Heart Failure

NCT ID: NCT01388855

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-07-31

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.

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%.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cholecalciferol

Patients were given two cholecalciferol tablets (10,000 IU each) daily for 30 days.

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

Subjects receive cholecalciferol 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks.

Placebo

Patients were given two cholecalciferol placebo tablets daily for 30 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pills made to look like vitamin D but have no medication in them

Interventions

Cholecalciferol

Subjects receive cholecalciferol 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks.

Intervention Type: DRUG

Placebo

Pills made to look like vitamin D but have no medication in them

Intervention Type: DRUG

Other Intervention Names

Vitamin D; sugar pill

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fraser Health

OTHER

Sponsor Role: lead

Responsible Party

Liz

Clinical Resource Dietitian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liz C da Silva, MS

Role: PRINCIPAL_INVESTIGATOR

Fraser Health Authority

Locations

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Countries

Canada

Other Identifiers

2011-028

Identifier Type: -

Identifier Source: org_study_id