- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01214928
Hemodialysis Vitamin D Pilot
July 19, 2011 updated by: St. Joseph's Healthcare Hamilton
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant is ≥ 18 years
Participant is on hemodialysis ≥ 3 months
Exclusion Criteria:
- Serum calcium >2.75 mmol/L
- 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®)
- Known hypersensitivity or allergy to Vitamin D
- End stage liver disease
- Severe untreated malabsorption or resection of large segment of small bowel
- Lack of informed consent or inability to consent
- Currently enrolled in a RCT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cholecalciferol
Cholecalciferol 50,000IU po once weekly for 12 continuous weeks.
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cholecalciferol 50,000 IU po once weekly for 12 weeks
Other Names:
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Placebo Comparator: Placebo
Matching placebo po once weekly for 12 continuous weeks
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cholecalciferol 50,000 IU po once weekly for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility objectives for this proof-of-concept study
Time Frame: 1 year
|
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Minute Walk Test
Time Frame: 1 year
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1. To determine the proportion of eligible patients that are able to complete a baseline and end of study 6-minute walk test.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
October 4, 2010
First Posted (Estimate)
October 5, 2010
Study Record Updates
Last Update Posted (Estimate)
July 20, 2011
Last Update Submitted That Met QC Criteria
July 19, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Renal Insufficiency, Chronic
- Vitamin D Deficiency
- Kidney Failure, Chronic
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- SJH PSI 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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