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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Valve Replacement Complication

Intervention / Treatment
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* Drug: Alfacalcidol 1 MCG Oral Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized ,controlled, open-label, parallel clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alfacalcidol<br>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. | Drug: Alfacalcidol 1 MCG Oral Capsule<br>* 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<br>* Other names: Bone care;|
| No Intervention: Control<br>Control group were exposed to the same conditions as the treatment group except they were not given one-alfacalcidol. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital length of stay | length of hospital stay in days starting from ICU admission to hospital discharge. | time to hospital discharge, up to 15 days | 
| intensive-care unite length of stay | length of hospital stay in hours starting from ICU admission to ICU discharge. | time to ICU discharge, up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative complications | compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms | during hospital stay, up to 15 days | 
| mortality | compare mortality rate between the 2 arms | during hospital stay, up to 15 days | 
| monitor alfacalcidol safety | 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 | during hospital stay, up tp 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LOS, mediastinitis, secondary myocardial infection