Hemodialysis Vitamin D Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

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.

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Detailed Description

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Conditions

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Vitamin D Deficiency Renal Failure Chronic Requiring Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cholecalciferol

Cholecalciferol 50,000IU po once weekly for 12 continuous weeks.

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

cholecalciferol 50,000 IU po once weekly for 12 weeks

Placebo

Matching placebo po once weekly for 12 continuous weeks

Group Type PLACEBO_COMPARATOR

Cholecalciferol

Intervention Type DRUG

cholecalciferol 50,000 IU po once weekly for 12 weeks

Interventions

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Cholecalciferol

cholecalciferol 50,000 IU po once weekly for 12 weeks

Intervention Type DRUG

Other Intervention Names

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vitamin D3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No