Hemodialysis Vitamin D Pilot

NCT01214928 | Completed DMC

• 1 other identifier: SJH PSI 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Renal Failure Chronic Requiring Hemodialysis

Keywords

vitamin D; cholecalciferol; hemodialysis; randomized controlled trial; pilot

Outcome Measures

Primary Outcomes (1)

• Feasibility objectives for this proof-of-concept study

  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.

  1 year

Secondary Outcomes (1)

• Six Minute Walk Test

  1 year

Study Arms (2)

Cholecalciferol

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Matching placebo po once weekly for 12 continuous weeks

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

cholecalciferol 50,000 IU po once weekly for 12 weeks

Also known as: vitamin D3

Cholecalciferol; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is ≥ 18 years
• Participant is on hemodialysis ≥ 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: October 5, 2010
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

CA (1)