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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00707785
First received: June 27, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 27, 2008
June 27, 2008
December 2006
January 2010   (final data collection date for primary outcome measure)
  • Disease Mortality [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Disease Progression [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Treatment Failure [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Time to recovery [ Time Frame: prospective ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Inflammatory cytokine concentration [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Duration of inflammation [ Time Frame: prospective ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Vitamin A in the Treatment of Neontal 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 facilitate recovery from sepis 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sepsis
  • Necrotizing Enterocolitis
  • Meningitis
  • Pneumonia
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A
  • Active Comparator: 1
    Sepsis - Vitamin A
    Intervention: Dietary Supplement: Vitamin A
  • Placebo Comparator: 2
    Sepsis -Placebo
    Intervention: Dietary Supplement: Vitamin A
  • Active Comparator: 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.
 
Recruiting
516
January 2010
January 2010   (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. cholestatis)
  • definite or severe NEC (> stage 2)
  • congenital heart disease
  • Infants receiving VA supplements
  • Infants requiring mechanical ventilation
  • Infant is unconscious
Both
up to 28 Days
No
Contact: Christian L Coles, PhD 443.287.1933 ccoles@jhsph.edu
Contact: Keith P West, DrPH 410.955.2061 kwest@jhsph.edu
Bangladesh
 
NCT00707785
H.22.05.12.20.A2, 1 K01 DK075478-01
Yes
Christian L Coles, Johns Hopkins Bloomberg School of Public Health
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
June 2008

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