Hemodialysis Vitamin D Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01214928
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : July 20, 2011
The Physicians' Services Incorporated Foundation
Information provided by:
St. Joseph's Healthcare Hamilton

August 30, 2010
October 5, 2010
July 20, 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 ]
  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 Archive Site
Six Minute Walk Test [ Time Frame: 1 year ]
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
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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