We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00707785
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : September 25, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Sepsis Necrotizing Enterocolitis Meningitis Pneumonia Dietary Supplement: Vitamin A Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates
Study Start Date : December 2006
Primary Completion Date : April 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Sepsis - vitamin A
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A 50,000 IU of vegetable oil
Other Name: Retinol
Placebo Comparator: 2
Sepsis - placebo
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A 50,000 IU of vegetable oil
Other Name: Retinol
Experimental: 3
NEC - vitamin A
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A 50,000 IU of vegetable oil
Other Name: Retinol
Placebo Comparator: 4
NEC - Placebo
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A 50,000 IU of vegetable oil
Other Name: Retinol

Outcome Measures

Primary Outcome Measures :
  1. Disease Mortality [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. Inflammatory cytokine concentration [ Time Frame: prospective ]
  2. Duration of inflammation [ Time Frame: prospective ]
  3. Disease progression in NEC patients [ Time Frame: prospective ]

Other Outcome Measures:
  1. Treatment failure [ Time Frame: prospective ]
  2. Time to recovery from severe illness [ Time Frame: prospective ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707785

Dhaka Shishu Hospital
Dhaka, Bangladesh
Sponsors and Collaborators
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
More Information

Responsible Party: Christian Coles, Assistant Professor, Department of International Health, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00707785     History of Changes
Other Study ID Numbers: H.
1K01DK075478-01 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

Keywords provided by Christian Coles, Johns Hopkins University:
vitamin A
necrotizing enterocolitis

Additional relevant MeSH terms:
Enterocolitis, Necrotizing
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents