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| 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) |
|---|---|
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00707785 |
Purpose
The purpose of the study is to determine whether vitamin A can facilitate recovery from sepis and necrotizing enterocolitis in hospitalized neonates.
| Condition | Intervention | Phase |
|---|---|---|
|
Sepsis Necrotizing Enterocolitis Meningitis Pneumonia |
Dietary Supplement: Vitamin A |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates |
| Estimated Enrollment: | 516 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Sepsis - Vitamin A
|
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A
|
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2: Placebo Comparator
Sepsis -Placebo
|
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A
|
|
3: Active Comparator
NEC -Vitamin A
|
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A
|
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4: Placebo Comparator
NEC - Placebo
|
Dietary Supplement: Vitamin A
50,000 IU of Vitamin A
|
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:
Exclusion Criteria:
Contacts and Locations| Contact: Christian L Coles, PhD | 443.287.1933 | ccoles@jhsph.edu |
| Contact: Keith P West, DrPH | 410.955.2061 | kwest@jhsph.edu |
| Bangladesh | |
| Dhaka Shishu Hospital | Recruiting |
| Dhaka, Bangladesh | |
| Contact: Monir Hossain, M.D. +880 21711 mhosain@bdcom.com | |
| Contact: Samir Saha, PhD 880 2 816061-2 sksaha@bangla.net | |
| Principal Investigator: Monir L Hossain, MD | |
| Sub-Investigator: Samir Saha, PhD | |
| Sub-Investigator: Mahfuza Shirin, FCPS | |
| Principal Investigator: | Christian L Coles, PhD | Johns Hopkins Bloomberg School of Public Health |
More Information
| Responsible Party: | Johns Hopkins Bloomberg School of Public Health ( Christian L Coles ) |
| Study ID Numbers: | H.22.05.12.20.A2, 1 K01 DK075478-01 |
| Study First Received: | June 27, 2008 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00707785 |
| Health Authority: | United States: Institutional Review Board |
|
vitamin A Treatment neonates newborn |
sepis necrotizing enterocolitis meningitis pneumonia |
|
Systemic Inflammatory Response Syndrome Gastrointestinal Diseases Necrotizing enterocolitis Central Nervous System Diseases Intestinal Diseases Enterocolitis Inflammation Meningitis Sepsis Digestive System Diseases |
Retinol palmitate Respiratory Tract Infections Central Nervous System Infections Respiratory Tract Diseases Vitamin A Lung Diseases Enterocolitis, Necrotizing Gastroenteritis Pneumonia |
|
Anticarcinogenic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs |
Infection Protective Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Vitamins Micronutrients |
