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Completed

NCT Number: NCT04085770

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

El-Demerdash Cardiac Academy Hospital, Ain Shams University

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Bone care

Primary outcomes

  1. hospital length of stay

    Time frame: 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 frame: time to ICU discharge, up to 7 days

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

Secondary outcomes

  1. Rate of postoperative complications

    Time frame: 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

    Time frame: during hospital stay, up to 15 days

    compare mortality rate between the 2 arms

  3. monitor alfacalcidol safety

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 11, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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