Status:
COMPLETED
Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
Lead Sponsor:
Cairo University
Conditions:
Cardiac Valve Replacement Complication
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other h...
Detailed Description
Vitamin D insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (ICU), including cardiac surgical patients. Moreover, 25(OH)D levels continue...
Eligibility Criteria
Inclusion
- patients undergoing mechanical valve replacement surgery
Exclusion
- combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery
- valvular replacement redo
- valvular replacement surgery secondary to infective endocarditis
- on dialysis
- ALT levels 2-3 times higher than normal range
- CHD,
- impaired gastrointestinal function
- indication for vitamin D supplementation within the prior month
- hypercalcemia defined as total calcium \>10.4 mg/dl
- hyperphosphatemia defined as serum phosphate \> 4.5 mg/dl
- pregnancy and lactation.
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2019
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04085770
Start Date
April 1 2017
End Date
September 3 2019
Last Update
September 11 2019
Active Locations (1)
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1
El-Demerdash Cardiac Academy Hospital, Ain Shams University
Cairo, Egypt, 11562