Pilot Study of Vitamin D Supplementation in Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Fraser Health.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Liz, Fraser Health
ClinicalTrials.gov Identifier:
NCT01388855
First received: June 22, 2011
Last updated: February 15, 2012
Last verified: February 2012

June 22, 2011
February 15, 2012
September 2011
July 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01388855 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Heart Failure
  • Drug: Cholecalciferol
    Subjects receive cholecalciferol 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks.
    Other Name: Vitamin D
  • Drug: Placebo
    Pills made to look like vitamin D but have no medication in them
    Other Name: sugar pill
  • Experimental: Cholecalciferol
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01388855
2011-028
No
Liz, Fraser Health
Fraser Health
Not Provided
Principal Investigator: Liz C da Silva, BHE Fraser Health
Fraser Health
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP