Hemodialysis Vitamin D Pilot

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Renal Failure Chronic Requiring Hemodialysis
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT01214928
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Cholecalciferol	Matching placebo po once weekly for 12 continuous weeks
Cholecalciferol	Cholecalciferol	Cholecalciferol 50,000IU po once weekly for 12 continuous weeks.

Primary Outcome Measures

Name	Time	Method
Feasibility objectives for this proof-of-concept study	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

Name	Time	Method
Six Minute Walk Test	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.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada