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

NCT04085770 | Completed Phase 4

• 1 other identifier: CL(1686)
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Valve Replacement Complication

Keywords

LOS; mediastinitis; secondary myocardial infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rate of postoperative complications

  during hospital stay, up to 15 days

• mortality

  during hospital stay, up to 15 days

• monitor alfacalcidol safety

  during hospital stay, up tp 15 days

Study Arms (2)

Alfacalcidol

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Alfacalcidol 1 MCG Oral Capsule 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

Also known as: Bone care

Alfacalcidol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing mechanical valve replacement surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El-Demerdash Cardiac Academy Hospital, Ain Shams University

Cairo, 11562, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33339609 DERIVED

MeSH Terms

Conditions

Mediastinitis

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: randomized ,controlled, open-label, parallel clinical trial

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 11, 2019
• Study Start: April 1, 2017
• Primary Completion: February 26, 2018
• Study Completion: September 3, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)