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Vitamin D Supplementation in Intensive Care Unit Patients

NCT04915963 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2021-06-18

No results posted yet for this study

Summary

A randomized controlled trial is designed to investigate the safety and clinical efficacy of a mega dose of VD in patients admitted in intensive care unit (ICU). Patients will be randomly allocated to receive 400,000 IU of VD3 or placebo. They will be followed up until ICU discharge or death or the 15th day of ICU stay. Adverse events that occur during ICU stay is collected. Primary outcome is intensive care unit-acquired infection (ICU-AI), and secondary outcomes are septic shock, organ failure, and ICU-mortality. Plasma 25-hydroxyvitamin D is assessed at baseline and at the end of follow-up. Cox regression models will be applied to test how VD supplementation affects adverse outcomes while adjusting for confounders.

Conditions

  • Dietary Supplements
  • Intensive Care Unit
  • Vitamin D Deficiency
  • Vitamin D Toxicity

Interventions

DIETARY_SUPPLEMENT

Vitamin D supplementation

Patients are randomized to receive vitamin D or placebo and followed up for 15 days at maximum to investigate the safety and clinical efficacy of the supplements

Sponsors & Collaborators

  • Faculty of Medicine of Tunis

    collaborator OTHER

  • Rabta University Hospital

    collaborator UNKNOWN

  • Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

    lead OTHER

Principal Investigators

  • Moncef Feki, Professor · Rabta University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-20
Primary Completion
2019-03-10
Completion
2019-05-30

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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 NCT04915963 on ClinicalTrials.gov