| Trial ID: | L0920 |
| Source ID: | NCT01312714
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Vitamin D3 Supplementation in Dialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-Stage Renal Disease
|
| Interventions: |
DRUG: Cholecalciferol|DRUG: Placebo
|
| Outcome Measures: |
Primary: Plasma concentration of NT-proBNP, 26 weeks | Secondary: Plasma concentration of ionized calcium, 4 weeks|Plasma concentration of phosphate, 4 weeks|Plasma concentration of PTH, 4 weeks|Plasma concentration of 25-hydroxycholecalciferol, 4 weeks|24-hour blood pressure, 26 weeks|Plasma renin concentration, 26 weeks|Plasma concentration of angiotensin II, 26 weeks|Plasma concentration of aldosterone, 26 weeks|Arterial stiffness, 26 weeks|Serum concentration of FGF-23, 26 weeks|Plasma concentration of AVP, 26 weeks|Plasma concentration of ANP, 26 weeks|Plasma concentration of TNF alpha, 26 weeks|Heart Function, 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Regional Hospital Holstebro
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-02
|
| Completion Date: |
2012-09
|
| Results First Posted: |
|
| Last Update Posted: |
2013-05-29
|
| Locations: |
Departments of Medical Research and Medicine, Holstebro Hospital, Holstebro, 7500, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT01312714
|