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

Sepsis Clinical Trial

Official title:

Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707785
• Other study ID #: H.22.05.12.20.A2
• Secondary ID: 1K01DK075478-01
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2008
• Last updated: September 24, 2013
• Start date: December 2006
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: June 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• newborns less than 29 days with clinical sepsis

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Meningitis
• Necrotizing Enterocolitis
• Pneumonia
• Sepsis
• Toxemia

Intervention

Dietary Supplement:
• Vitamin A
50,000 IU of Vitamin A 50,000 IU of vegetable oil

Locations

Country	Name	City	State
Bangladesh	Dhaka Shishu Hospital	Dhaka

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Bill and Melinda Gates Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Agency for International Development (USAID)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment failure		prospective	No
Other	Time to recovery from severe illness		prospective	No
Primary	Disease Mortality		prospective	No
Secondary	Inflammatory cytokine concentration		prospective	No
Secondary	Duration of inflammation		prospective	No
Secondary	Disease progression in NEC patients		prospective	No