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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Annamalai University |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00255385 |
The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.
Condition | Intervention | Phase |
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Diarrhea Pneumonia Febrile Illness Growth Child Development |
Drug: Micronutrient (Zinc and Iron) fortification Drug: Pre and Probiotic fortification |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months |
Estimated Enrollment: | 1200 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | April 2004 |
The 1993 World Bank World Development Report (1) delivered a strong but sad reminder of the dramatic scale of suffering and death among preschool children attributable to pneumonia (2.7million in 1990) and diarrhea (another 2.5million deaths). In terms of “disability adjusted life years” (DALYS) lost, in 0-4 years old children, respiratory infections account for 18.5% and 17.6% (in boys & girls respectively) and diarrhea accounts of another 16.2% and 15.7% respectively. The development of effective interventions to reduce morbidity from these illnesses has become a humanitarian, economic and political imperative and essential in achieving the morbidity and mortality reduction goals that the “World Summit for Children” set a decade ago. Therapy with Oral Rehydration Solution (ORS) for diarrhea, a cornerstone of the universal strategy for child survival, has low compliance due to having no effect on duration of diarrhea and has mixed impact on child mortality (2-5). Present strategies for containing morbidity and mortality due to respiratory infection focuses primarily on antibiotic treatment. Increasing prevalence of antibiotic resistant strains, poses a problem with the current strategy. Lack of any truly effective and affordable preventive vaccine, for both diarrhea and pneumonia has aroused considerable interest in food based preventive interventions. In the recent years increasing recognition and evidence regarding the role of Probiotics, and micronutrients like Zinc, as both preventive and therapeutic agents against infections has made them a potential and promising candidate. This study is in fact two trial run concurrently with two milk preparation one fortified with pre and Probiotics and second fortified with micronutrients and each having same milk unfortified as control.
Ages Eligible for Study: | 12 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India | |
Center for Micronutrient Research | |
New Delhi, India, 110024 |
Principal Investigator: | Sunil Sazawal, MD, MPH, PHD | Johns Hopkins University |
Principal Investigator: | VenuGopal P Menon, PhD | Annamalai University |
Principal Investigator: | Robert E Black, MD, MPH | Johns Hopkins University |
Study ID Numbers: | H22010703A |
Study First Received: | November 16, 2005 |
Last Updated: | November 16, 2005 |
ClinicalTrials.gov Identifier: | NCT00255385 History of Changes |
Health Authority: | United States: Institutional Review Board |
Zinc Iron Probiotics Prebiotics |
Child health Milk fortification Randomized controlled trial |
Fever Signs and Symptoms Diarrhea Respiratory Tract Infections Respiratory Tract Diseases Signs and Symptoms, Digestive |
Lung Diseases Zinc Trace Elements Micronutrients Iron Pneumonia |
Signs and Symptoms Diarrhea Respiratory Tract Infections Respiratory Tract Diseases Signs and Symptoms, Digestive Growth Substances |
Lung Diseases Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions Pneumonia |