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

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ClinicalTrials.gov Identifier: NCT00707785
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : September 25, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

June 27, 2008
July 1, 2008
September 25, 2013
December 2006
April 2011   (Final data collection date for primary outcome measure)
Disease Mortality [ Time Frame: prospective ]
  • Disease Mortality [ Time Frame: prospective ]
  • Disease Progression [ Time Frame: prospective ]
  • Treatment Failure [ Time Frame: prospective ]
  • Time to recovery [ Time Frame: prospective ]
Complete list of historical versions of study NCT00707785 on ClinicalTrials.gov Archive Site
  • Inflammatory cytokine concentration [ Time Frame: prospective ]
  • Duration of inflammation [ Time Frame: prospective ]
  • Disease progression in NEC patients [ Time Frame: prospective ]
  • Inflammatory cytokine concentration [ Time Frame: prospective ]
  • Duration of inflammation [ Time Frame: prospective ]
  • Treatment failure [ Time Frame: prospective ]
  • Time to recovery from severe illness [ Time Frame: prospective ]
Not Provided
 
Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis
Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sepsis
  • Necrotizing Enterocolitis
  • Meningitis
  • Pneumonia
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A 50,000 IU of vegetable oil
Other Name: Retinol
  • Experimental: 1
    Sepsis - vitamin A
    Intervention: Dietary Supplement: Vitamin A
  • Placebo Comparator: 2
    Sepsis - placebo
    Intervention: Dietary Supplement: Vitamin A
  • Experimental: 3
    NEC - vitamin A
    Intervention: Dietary Supplement: Vitamin A
  • Placebo Comparator: 4
    NEC - Placebo
    Intervention: Dietary Supplement: Vitamin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
424
June 2012
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 28 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
 
NCT00707785
H.22.05.12.20.A2
1K01DK075478-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Christian Coles, Johns Hopkins University
Johns Hopkins University
  • Bill and Melinda Gates Foundation
  • United States Agency for International Development (USAID)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Christian L Coles, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP