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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.
ClinicalTrials.gov Identifier: NCT01214928
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : July 20, 2011
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Renal Failure Chronic Requiring Hemodialysis Drug: Cholecalciferol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study
Study Start Date : January 2011
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Cholecalciferol
Cholecalciferol 50,000IU po once weekly for 12 continuous weeks.
Drug: Cholecalciferol
cholecalciferol 50,000 IU po once weekly for 12 weeks
Other Name: vitamin D3
Placebo Comparator: Placebo
Matching placebo po once weekly for 12 continuous weeks
Drug: Cholecalciferol
cholecalciferol 50,000 IU po once weekly for 12 weeks
Other Name: vitamin D3

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214928

Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
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
More Information

Responsible Party: Dr. Catherine Clase, Nephrologist, Associate Professor, St. Joseph's Healthcare Hamilton, McMaster University
ClinicalTrials.gov Identifier: NCT01214928     History of Changes
Other Study ID Numbers: SJH PSI 001
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by St. Joseph's Healthcare Hamilton:
vitamin D
randomized controlled trial

Additional relevant MeSH terms:
Renal Insufficiency
Vitamin D Deficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Deficiency Diseases
Nutrition Disorders
Renal Insufficiency, Chronic
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents