NCT04085770

Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 half-the control group- will be exposed to the same environment without receiving alfacalcidol.

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 to decrease from baseline throughout the hospital stay and resolves by 6 months. Vitamin D levels \< 20 ng/ml is associated with higher mortality, infection rates and prolonged length of ICU saty. The discovery of vitamin D receptors (VDR) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin D regulates RAAS activity and cardiac remodeling. The beneficial effects of vitamin D on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.

Conditions

• Cardiac Valve Replacement Complication

Interventions

Type	Name	Description
DRUG	Alfacalcidol 1 MCG Oral Capsule	2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-02-26
• Completion: 2019-09-03
• First posted: 2019-09-11
• Last updated: 2019-09-11

Locations

1 site across 1 country: Egypt