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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Cardiac Valve Replacement Complication

Treatments: Drug: Alfacalcidol 1 MCG Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04085770

CL(1686)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Alfacalcidol

Experimental group

Description:

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.

Treatment:

Drug: Alfacalcidol 1 MCG Oral Capsule

Control

No Intervention group

Description:

Control group were exposed to the same conditions as the treatment group except they were not given one-alfacalcidol.