Hemodialysis Vitamin D Pilot

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214928
• Other study ID #: SJH PSI 001
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: July 19, 2011
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
cholecalciferol 50,000 IU po once weekly for 12 weeks

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No