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Trial record 1 of 1 for:    NCT00255385.
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Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255385
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : November 18, 2005
Annamalai University
Information provided by:
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
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 or disease Intervention/treatment Phase
Diarrhea Pneumonia Febrile Illness Growth Child Development Drug: Micronutrient (Zinc and Iron) fortification Drug: Pre and Probiotic fortification Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2002
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Diarrhea
  2. Pneumonia
  3. Febrile illness
  4. Growth
  5. Development
  6. Activity

Secondary Outcome Measures :
  1. Iron status
  2. Zinc status
  3. Colonization
  4. Copper status

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255385

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Center for Micronutrient Research
New Delhi, India, 110024
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Annamalai University
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00255385    
Other Study ID Numbers: H22010703A
First Posted: November 18, 2005    Key Record Dates
Last Update Posted: November 18, 2005
Last Verified: April 2005
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Child health
Milk fortification
Randomized controlled trial
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Trace Elements
Growth Substances
Physiological Effects of Drugs