Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Vitamin A Deficiency; Pediatric
• Intervention / Treatment: Drug: Vitamin A; Drug: Oil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention group; Septic children with vitamin A deficiency who will receive vitamin A supplementation.	Drug: Vitamin A; Children in intervention group will receive 50,000 IU vitamin A after being randomized.
PLACEBO_COMPARATOR: control group; Septic children with vitamin A deficiency who will receive placebo.	Drug: Oil; Children in control group will receive equal volume of oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	The length of hospital stay will be measured by days	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital mortality	Hospital mortality will be record as ratio	2 years

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): May 31, 2024

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (ACTUAL): October 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 1, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Eye Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Sepsis; Toxemia; Night Blindness; Vitamin A Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 1010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No