Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin A Deficiency Pediatric Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

Vitamin A

Intervention Type DRUG

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

control group

Septic children with vitamin A deficiency who will receive placebo.

Group Type PLACEBO_COMPARATOR

Oil

Intervention Type DRUG

Children in control group will receive equal volume of oil.

Interventions

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Vitamin A

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

Intervention Type DRUG

Oil

Children in control group will receive equal volume of oil.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

0 Months

Maximum Eligible Age

192 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No