Pilot Study of Vitamin D Supplementation in Heart Failure

NCT01388855 | Completed

• 1 other identifier: 2011-028
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Vitamin D; Pain; Pilot Study; RCT

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

  8 months

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

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

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cholecalciferol DRUG

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

Also known as: Vitamin D

Cholecalciferol

Placebo DRUG

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

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

MeSH Terms

Conditions

Heart Failure; Pain

Interventions

Cholecalciferol; Vitamin D; Sugars

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Carbohydrates

Study Officials

• Liz C da Silva, MS

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Resource Dietitian

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: July 7, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

CA (1)