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Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency.

NCT02868827 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2020-06-18

No results posted yet for this study

Summary

The purpose of the research study is to determine whether a single high dose of vitamin D is helpful in reducing critical illness related complications in intensive care patients who are having sever vitamin D deficiency.

Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A number of scientific studies have documented a strong correlation between low levels of vit.D and increased rate of adverse outcomes including infection, acute kidney injury and mortality in ICU patients. A recent randomized controlled trial (RCT) has demonstrated a 50% reduction in hospital mortality in severe vit.D deficient patients following a single high dose of cholecalciferol (Vitamin D3). However, the role of Vit.D supplementation to boost up host immune system and eventually reduction of mortality has yet to be determined by large randomized controlled trials in humans. Hence the study aims to run a randomized controlled trial (RCT) in order to study the role of Vitamin D in critically ill patients.

Conditions

  • Vitamin D Deficiency
  • Critical Illness

Interventions

DRUG

Cholecalciferol

400000 international Units of cholecalciferol will be dissolved in 45 ml of fresh milk (Nestle) and it will be given to interventional group patients through enteral route within 24 hours of ICU admission as a single dose.

OTHER

Milk (Nestle)

45 ml of Nestle milk will given to patients assigned as placebo

Sponsors & Collaborators

  • King Abdullah Medical City

    lead OTHER_GOV

Principal Investigators

  • Asiah S Rugaan, MD, MRCP · King Abdullah Medical City Makkah

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-27
Primary Completion
2019-11-09
Completion
2019-11-09

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02868827 on ClinicalTrials.gov