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


N/A
18 Years
N/A
Not Enrolling
Both
Vitamin D Deficiency, Renal Failure Chronic Requiring Hemodialysis

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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

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