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

This study has been completed.
Sponsor:
Collaborator:
Annamalai University
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00255385
First received: November 16, 2005
Last updated: NA
Last verified: April 2005
History: No changes posted
  Purpose

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
Diarrhea
Pneumonia
Febrile Illness
Growth
Child Development
 Drug: Micronutrient (Zinc and Iron) fortification
Drug: Pre and Probiotic fortification
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Diarrhea
  • Pneumonia
  • Febrile illness
  • Growth
  • Development
  • Activity

Secondary Outcome Measures:
  • Iron status
  • Zinc status
  • Colonization
  • Copper status

Estimated Enrollment: 1200
Study Start Date: April 2002
Estimated Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255385

Locations
India
Center for Micronutrient Research
New Delhi, India, 110024
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Annamalai University
Investigators
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
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00255385     History of Changes
Other Study ID Numbers: H22010703A
Study First Received: November 16, 2005
Last Updated: November 16, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Zinc
Iron
Probiotics
Prebiotics
 Child health
Milk fortification
Randomized controlled trial

Additional relevant MeSH terms:
Diarrhea
Pneumonia
Signs and Symptoms, Digestive
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Micronutrients
Zinc
Iron
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013