Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis

Phase 3

Completed

• Conditions: Sepsis; Necrotizing Enterocolitis; Pneumonia; Meningitis
• Interventions: Dietary Supplement: Vitamin A

• Registration Number: NCT00707785
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of the study is to determine whether vitamin A can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.

Detailed Description

Sepsis and necrotizing enterocolitis (NEC) are leading causes of morbidity and mortality in neonates. Studies have shown that early reversal of the signs associated with severe disease is an important prognostic factor during acute illness. Vitamin A deficiency is widespread among children, including neonates, in developing countries. Vitamin A plays an important role in mediating immune responses and in maintaining epithelial integrity. For this reason vitamin A supplementation during the acute phase of neonatal infection could work synergistically with present antibiotic regimens in promoting early reversal of signs associated with adverse outcome and shorten the total duration of clinical illness. The purpose of the proposed hospital-based clinical trial is to evaluate the efficacy of vitamin A supplementation on reducing the morbidity and mortality among neonates hospitalized with sepsis (n=366) and NEC(n=150). Enrolled subjects will be randomized at the time of hospitalization to receive one dose of either 50,000 IU of vitamin A or placebo at enrollment, in addition to standard antibiotic therapy. We will compare the proportion of treatment failures in sepsis patients, the frequency of disease progression and mortality in NEC patients, and the time to clinical recovery and discharge between treatment groups. In addition, the study will determine whether vitamin A reduces pro-inflammatory cytokine levels; elevated host inflammatory cytokines are thought to contribute to the severity of both conditions. If vitamin A is found to be efficacious in the treatment of sepsis and NEC it could present a needed cost-effective approach to decreasing the global morbidity, mortality and the economic cost associated with neonatal sepsis and NEC in the developing world.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-01
• Primary Completion: 2011-04
• Study Completion: 2012-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

• newborns less than 29 days with clinical sepsis

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Exclusion Criteria

• healthy infants
• major congenital abnormalities
• known inborn error(s) of metabolism
• chronic disorders of other organs (e.g. cholestasis)
• definite or severe NEC (> stage 2)
• congenital heart disease
• Infants receiving VA supplements
• Infants requiring mechanical ventilation
• Infant is unconscious

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vitamin A	Sepsis - vitamin A
4	Vitamin A	NEC - Placebo
2	Vitamin A	Sepsis - placebo
3	Vitamin A	NEC - vitamin A

Primary Outcome Measures

Name	Time	Method
Disease Mortality	prospective

Secondary Outcome Measures

Name	Time	Method
Inflammatory cytokine concentration	prospective
Duration of inflammation	prospective
Disease progression in NEC patients	prospective

Trial Locations

Locations (1)

Dhaka Shishu Hospital; 🇧🇩 Dhaka, Bangladesh