Trial Information
Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Feasibility objectives for this proof-of-concept study
Outcome Description:
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.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Karen CY To, MD, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Joseph's Health Care London
Authority:
Canada: Health Canada
Study ID:
SJH PSI 001
NCT ID:
NCT01214928
Start Date:
January 2011
Completion Date:
June 2011
Related Keywords:
- Vitamin D Deficiency
- Renal Failure Chronic Requiring Hemodialysis
- vitamin D
- cholecalciferol
- hemodialysis
- randomized controlled trial
- pilot
- Kidney Failure, Chronic
- Renal Insufficiency
- Vitamin D Deficiency