Clinical trial NCT01388855: Pilot Study of Vitamin D Supplementation in Heart Failure
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin D in Heart Failure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Vitamin D
Pain
Pilot Study
RCT
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 13
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: Rate of participant recruitment
timeFrame: 6 months
measure: Participant compliance with study procedures
timeFrame: 6 months
measure: Participant rate of retention
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with hypercalcemia as a measure of safety and tolerability.
timeFrame: 6 months
measure: Number of participants that achieve a target serum 25-hydroxyvitamin D of 75nmol/L
timeFrame: 8 months
measure: The values achieved for quality of life and pain questionnaire and functional capacity measure.
timeFrame: 8 months
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: Liz C da Silva, MS
role: PRINCIPAL_INVESTIGATOR
References: