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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04085770
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
29.1
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alfacalcidol 1 MCG Oral Capsule
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized ,controlled, open-label, parallel clinical trialrandomized ,controlled, open-label, parallel clinical trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
Actual Study Start Date :
Apr 1, 2017
Actual Primary Completion Date :
Feb 26, 2018
Actual Study Completion Date :
Sep 3, 2019

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. hospital length of stay [time to hospital discharge, up to 15 days]

      length of hospital stay in days starting from ICU admission to hospital discharge.

    2. intensive-care unite length of stay [time to ICU discharge, up to 7 days]

      length of hospital stay in hours starting from ICU admission to ICU discharge.

    Secondary Outcome Measures

    1. Rate of postoperative complications [during hospital stay, up to 15 days]

      compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms

    2. mortality [during hospital stay, up to 15 days]

      compare mortality rate between the 2 arms

    3. monitor alfacalcidol safety [during hospital stay, up tp 15 days]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 El-Demerdash Cardiac Academy Hospital, Ain Shams University Cairo Egypt 11562

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sandra Nael Naguib Wahba, Teaching Assistant, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04085770
    Other Study ID Numbers:
    • CL(1686)
    First Posted:
    Sep 11, 2019
    Last Update Posted:
    Sep 11, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sandra Nael Naguib Wahba, Teaching Assistant, Cairo University
    LOS
    mediastinitis
    secondary myocardial infection
    Additional relevant MeSH terms:
    Alfacalcidol
    Hydroxycholecalciferols

    Study Results

    No Results Posted as of Sep 11, 2019