Pediatric, Sepsis, Vitamin A Deficiency
Conditions
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.
Interventions
DRUGVitamin A
Children in intervention group will receive 50,000 IU vitamin A after being randomized.
DRUGOil
Children in control group will receive equal volume of oil.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
0 Months to 192 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | 2 years | The length of hospital stay will be measured by days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospital mortality | 2 years | Hospital mortality will be record as ratio |
Outcome results
None listed