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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Valve Replacement Complication
• Intervention / Treatment: Drug: Alfacalcidol 1 MCG Oral Capsule

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • El-Demerdash Cardiac Academy Hospital, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: Bone care
No Intervention: Control; Control group were exposed to the same conditions as the treatment group except they were not given one-alfacalcidol.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Naguib SN, Sabry NA, Farid SF, Alansary AM. Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial. Clin Ther. 2021 Jan;43(1):e1-e18. doi: 10.1016/j.clinthera.2020.11.008. Epub 2020 Dec 16.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): February 26, 2018
• Study Completion (Actual): September 3, 2019

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 7, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 7, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: LOS; mediastinitis; secondary myocardial infection
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Alfacalcidol; Hydroxycholecalciferols
• Other Study ID Numbers: CL(1686)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No