Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
- Registration Number
- NCT04127968
- Lead Sponsor
- West China Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Oil Septic children with vitamin A deficiency who will receive placebo. intervention group Vitamin A Septic children with vitamin A deficiency who will receive vitamin A supplementation.
- Primary Outcome Measures
Name Time Method length of hospital stay 2 years The length of hospital stay will be measured by days
- Secondary Outcome Measures
Name Time Method hospital mortality 2 years Hospital mortality will be record as ratio