NCT04127968

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
3 years until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

October 12, 2019

Last Update Submit

January 1, 2022

Conditions

Vitamin A DeficiencyPediatricSepsis

Outcome Measures

Primary Outcomes (1)

  • length of hospital stay

    The length of hospital stay will be measured by days

    2 years

Secondary Outcomes (1)

  • hospital mortality

    2 years

Study Arms (2)

intervention group

EXPERIMENTAL

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

Drug: Vitamin A

control group

PLACEBO COMPARATOR

Septic children with vitamin A deficiency who will receive placebo.

Drug: Oil

Interventions

Vitamin ADRUG

Children in intervention group will receive 50,000 IU vitamin A after being randomized.

intervention group
OilDRUG

Children in control group will receive equal volume of oil.

control group

Eligibility Criteria

Age0 Months - 192 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fu Q, Liu M, Zhang X, Fu J, Zhang G, Ji Y, Chen S. A randomized controlled trial on the efficacy and safety of vitamin A supplementation in children with sepsis. Front Pediatr. 2025 Aug 6;13:1579006. doi: 10.3389/fped.2025.1579006. eCollection 2025.

    PMID: 40843069DERIVED

MeSH Terms

Conditions

Vitamin A DeficiencySepsis

Interventions

Vitamin AOils

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 12, 2019

First Posted

October 16, 2019

Study Start

November 1, 2022

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

January 4, 2022

Record last verified: 2022-01