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

Cairo University (CU) logo

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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