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Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

Primary Purpose

Vitamin A Deficiency, Pediatric, Sepsis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin A
Oil
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin A Deficiency

Eligibility Criteria

0 Months - 192 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age < 18 years,
  2. Expected to stay in the ICU for 48 hours or more,
  3. Vitamin A deficiency (VA < 0.2 mg/L)

Exclusion Criteria:

  1. Severely impaired gastrointestinal function
  2. Premature infants and low birth weight (LBW) infants
  3. Condition of underlying organ dysfunction
  4. Having received chemotherapy or radiotherapy
  5. Hematological malignancies
  6. Primary or acquired immunodeficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    intervention group

    control group

    Arm Description

    Septic children with vitamin A deficiency who will receive vitamin A supplementation.

    Septic children with vitamin A deficiency who will receive placebo.

    Outcomes

    Primary Outcome Measures

    length of hospital stay
    The length of hospital stay will be measured by days

    Secondary Outcome Measures

    hospital mortality
    Hospital mortality will be record as ratio

    Full Information

    First Posted
    October 12, 2019
    Last Updated
    January 1, 2022
    Sponsor
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04127968
    Brief Title
    Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
    Official Title
    Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.
    Detailed Description
    It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin A Deficiency, Pediatric, Sepsis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    Septic children with vitamin A deficiency who will receive vitamin A supplementation.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    Septic children with vitamin A deficiency who will receive placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin A
    Intervention Description
    Children in intervention group will receive 50,000 IU vitamin A after being randomized.
    Intervention Type
    Drug
    Intervention Name(s)
    Oil
    Intervention Description
    Children in control group will receive equal volume of oil.
    Primary Outcome Measure Information:
    Title
    length of hospital stay
    Description
    The length of hospital stay will be measured by days
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    hospital mortality
    Description
    Hospital mortality will be record as ratio
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Months
    Maximum Age & Unit of Time
    192 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age < 18 years, Expected to stay in the ICU for 48 hours or more, Vitamin A deficiency (VA < 0.2 mg/L) Exclusion Criteria: Severely impaired gastrointestinal function Premature infants and low birth weight (LBW) infants Condition of underlying organ dysfunction Having received chemotherapy or radiotherapy Hematological malignancies Primary or acquired immunodeficiency

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

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