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Hemodialysis Vitamin D Pilot

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01214928
First received: August 30, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

August 30, 2010
July 19, 2011
January 2011
May 2011   (final data collection date for primary outcome measure)
Feasibility objectives for this proof-of-concept study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  1. To determine the proportion of consecutive HD patients that are eligible, the proportion of eligible patients that will consent to randomization, and of those randomized, the proportion that will comply with their group assignment.
  2. To determine the treatment effect of oral cholecalciferol compared with placebo in raising serum 25(OH)D and 1,25(OH)2D levels in HD patients.
Same as current
Complete list of historical versions of study NCT01214928 on ClinicalTrials.gov Archive Site
Six Minute Walk Test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
1. To determine the proportion of eligible patients that are able to complete a baseline and end of study 6-minute walk test.
Same as current
Not Provided
Not Provided
 
Hemodialysis Vitamin D Pilot
Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study

Vitamin D is a prohormone obtained through diet, supplementation, or sun exposure. Once absorbed, this nutritional vitamin D undergoes a two-step reaction in the liver and in the kidney to become the active hormone, calcitriol. Besides the kidney, many other body tissues are capable of local vitamin D activation. This local tissue activity is important for maintenance of health and relies on adequate levels of nutritional vitamin D. Not only are dialysis patients deficient in calcitriol due to kidney failure, but they are also deficiency in nutritional vitamin D. Low levels of vitamin D have been associated with higher rates of death, heart and blood vessel disease, osteoporosis, falls, cancer, and autoimmune diseases. Despite this, there is a lack of randomized controlled trials (RCT) examining the effects of nutritional vitamin D in hemodialysis (HD) patients. The investigators hypothesize that long-term supplementation with nutritional vitamin D in HD patients improves survival and cardiovascular outcomes. Before embarking on a large scale RCT, the investigators propose a small pilot RCT with 20 hemodialysis patients to: i) To determine the effects of cholecalciferol (vitamin D3) in raising blood vitamin D levels; ii) To determine the feasibility and barriers to successful randomization and adherence to treatment protocols, which will inform subsequent studies.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • Renal Failure Chronic Requiring Hemodialysis
Drug: Cholecalciferol
cholecalciferol 50,000 IU po once weekly for 12 weeks
Other Name: vitamin D3
  • Active Comparator: Cholecalciferol
    Cholecalciferol 50,000IU po once weekly for 12 continuous weeks.
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Matching placebo po once weekly for 12 continuous weeks
    Intervention: Drug: Cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participant is ≥ 18 years

  2. Participant is on hemodialysis ≥ 3 months

    Exclusion Criteria:

  3. Serum calcium >2.75 mmol/L
  4. On concurrent vitamin D treatment ≥ 800 IU/day. Includes ergocalciferol, cholecalciferol, calcedidiol, over-the-counter vitamin D. Does not include one-alpha calcidol (One Alfa®) or 1, 25 di-hydroxy-D3 (Rocaltrol® or Calcijex®)
  5. Known hypersensitivity or allergy to Vitamin D
  6. End stage liver disease
  7. Severe untreated malabsorption or resection of large segment of small bowel
  8. Lack of informed consent or inability to consent
  9. Currently enrolled in a RCT
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01214928
SJH PSI 001
Yes
Dr. Catherine Clase, Nephrologist, Associate Professor, St. Joseph's Healthcare Hamilton, McMaster University
St. Joseph's Healthcare Hamilton
The Physicians' Services Incorporated Foundation
Principal Investigator: Karen CY To, MD, FRCPC St. Joseph's Health Care London
Principal Investigator: Catherine Clase, FRCPC St. Joseph's Health Care London
Principal Investigator: Azim S Gangji, MD, FRCPC St. Joseph's Health Care London
St. Joseph's Healthcare Hamilton
July 2011

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