Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

West China Hospital450 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

450

Conditions

Vitamin A Deficiency Pediatric Sepsis

Interventions

Vitamin ADRUG

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

OilDRUG

Children in control group will receive equal volume of oil.

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 192 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

length of hospital stay

The length of hospital stay will be measured by days

Time frame: 2 years

Secondary Outcomes

hospital mortality

Hospital mortality will be record as ratio

Time frame: 2 years

Data from ClinicalTrials.gov

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