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NCT04127968 Clinical Trial

Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

Sepsis Clinical Trial

Official title:
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04127968
Other study ID # 1010
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date May 31, 2024

Study information
Verified date January 2022
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 450
Est. completion date May 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 192 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin A
Children in intervention group will receive 50,000 IU vitamin A after being randomized.
• Oil
Children in control group will receive equal volume of oil.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary length of hospital stay The length of hospital stay will be measured by days 2 years
Secondary hospital mortality Hospital mortality will be record as ratio 2 years
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