Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sepsis Necrotizing Enterocolitis Meningitis Pneumonia |
Dietary Supplement: Vitamin A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates |
- Disease Mortality [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Inflammatory cytokine concentration [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Duration of inflammation [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Disease progression in NEC patients [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Treatment failure [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Time to recovery from severe illness [ Time Frame: prospective ] [ Designated as safety issue: No ]
| Enrollment: | 424 |
| Study Start Date: | December 2006 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00707785
| Bangladesh | |
| Dhaka Shishu Hospital | |
| Dhaka, Bangladesh | |
| Principal Investigator: | Christian L Coles, PhD | Johns Hopkins Bloomberg School of Public Health |
More Information
No publications provided
| 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.22.05.12.20.A2, 1K01DK075478-01 |
| Study First Received: | June 27, 2008 |
| Last Updated: | September 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
vitamin A Treatment neonates newborn |
sepsis necrotizing enterocolitis meningitis pneumonia |
Additional relevant MeSH terms:
|
Retinol palmitate Vitamin A Enterocolitis Enterocolitis, Necrotizing Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Vitamins Anticarcinogenic Agents |
Antineoplastic Agents Antioxidants Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015