Hemodialysis Vitamin D Pilot

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
• Conditions: Vitamin D Deficiency; Renal Failure Chronic Requiring Hemodialysis
• Intervention / Treatment: Drug: Cholecalciferol

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

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:

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cholecalciferol; Cholecalciferol 50,000IU po once weekly for 12 continuous weeks.	Drug: Cholecalciferol; cholecalciferol 50,000 IU po once weekly for 12 weeks; Other Names: vitamin D3
Placebo Comparator: Placebo; Matching placebo po once weekly for 12 continuous weeks	Drug: Cholecalciferol; cholecalciferol 50,000 IU po once weekly for 12 weeks; Other Names: vitamin D3

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: The Physicians' Services Incorporated Foundation
• 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

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

• Keywords: randomized controlled trial; vitamin D; hemodialysis; cholecalciferol; pilot
• 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