| Trial ID: | L1560 |
| Source ID: | NCT01214928
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Hemodialysis Vitamin D Pilot
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Vitamin D Deficiency|Renal Failure Chronic Requiring Hemodialysis
|
| Interventions: |
DRUG: Cholecalciferol
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: St. Joseph's Healthcare Hamilton | Collaborators: The Physicians' Services Incorporated Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01
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| Completion Date: |
2011-06
|
| Results First Posted: |
|
| Last Update Posted: |
2011-07-20
|
| Locations: |
St. Joseph's Healthcare Hamilton, Hamilton, Ontario, L8N 4A6, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01214928
|