Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk

November 16, 2005 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110024
        • Center for Micronutrient Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 12-36 months at enrollment
  • Resident of Sangam Vihar and likely to be in the area for 1 year.
  • Parents consenting to participate in the trial.

Exclusion Criteria:

  • Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
  • Children currently as part of a different Iron/Zinc supplementation program.
  • Children known to be allergic to milk.
  • Children who are severely malnourished and requiring hospitalization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Growth
Pneumonia
Activity
Diarrhea
Febrile illness
Development

Secondary Outcome Measures

Outcome Measure
Iron status
Zinc status
Colonization
Copper status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Annamalai University

Investigators

  • Principal Investigator: VenuGopal P Menon, PhD, Annamalai University
  • Principal Investigator: Sunil Sazawal, MD, MPH, PHD, Johns Hopkins University
  • Principal Investigator: Robert E Black, MD, MPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

November 16, 2005

First Submitted That Met QC Criteria

November 16, 2005

First Posted (Estimate)

November 18, 2005

Study Record Updates

Last Update Posted (Estimate)

November 18, 2005

Last Update Submitted That Met QC Criteria

November 16, 2005

Last Verified

April 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22010703A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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