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

Phase 4

Completed

• Conditions: Cardiac Valve Replacement Complication
• Interventions: Drug: Alfacalcidol 1 MCG Oral Capsule

• Registration Number: NCT04085770
• Lead Sponsor: Cairo University

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 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.

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-02-26
• Status Verified: 2019-09
• Study Completion: 2019-09-03
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-07
• Last Update Submitted: 2019-09-07
• Study First Posted: 2019-09-11
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• patients undergoing mechanical valve replacement surgery

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alfacalcidol	Alfacalcidol 1 MCG Oral Capsule	Patients allocated to the alfacalcidol group received 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.

Primary Outcome Measures

Name	Time	Method
hospital length of stay	time to hospital discharge, up to 15 days	length of hospital stay in days starting from ICU admission to hospital discharge.
intensive-care unite length of stay	time to ICU discharge, up to 7 days	length of hospital stay in hours starting from ICU admission to ICU discharge.

Secondary Outcome Measures

Name	Time	Method
monitor alfacalcidol safety	during hospital stay, up tp 15 days	the measurement of alfacalcidol blood concentration indirectly through the measurement of serum 25(OH)D and monitoring of its metabolic effect through the measurement of serum total calcium and phosphorous
Rate of postoperative complications	during hospital stay, up to 15 days	compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms
mortality	during hospital stay, up to 15 days	compare mortality rate between the 2 arms

Trial Locations

Locations (1)

El-Demerdash Cardiac Academy Hospital, Ain Shams University; 🇪🇬 Cairo, Egypt