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
  Purpose

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 Intervention
Vitamin D Deficiency
Renal Failure Chronic Requiring Hemodialysis
Drug: Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214928

Locations
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
Investigators
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

No publications provided

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
Study First Received: August 30, 2010
Last Updated: July 19, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Renal Insufficiency
Vitamin D Deficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency, Chronic
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014