Hemodialysis Vitamin D Pilot

Study Overview
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Brief Summary
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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.

Official Title
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Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study

Conditions
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Vitamin D Deficiency, Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecalciferol<br>Cholecalciferol 50,000IU po once weekly for 12 continuous weeks. | Drug: Cholecalciferol<br>* cholecalciferol 50,000 IU po once weekly for 12 weeks<br>* Other names: vitamin D3;|
| Placebo Comparator: Placebo<br>Matching placebo po once weekly for 12 continuous weeks | Drug: Cholecalciferol<br>* cholecalciferol 50,000 IU po once weekly for 12 weeks<br>* Other names: vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility objectives for this proof-of-concept study | 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. 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test | 1. To determine the proportion of eligible patients that are able to complete a baseline and end of study 6-minute walk test. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, cholecalciferol, hemodialysis, randomized controlled trial, pilot