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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-09-03

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.

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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.

Conditions

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Cardiac Valve Replacement Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized ,controlled, open-label, parallel clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Alfacalcidol

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.

Group Type EXPERIMENTAL

Alfacalcidol 1 MCG Oral Capsule

Intervention Type DRUG

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Bone care

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No