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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255385
• Other study ID #: H22010703A
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2005
• Last updated: November 16, 2005
• Start date: April 2002
• Est. completion date: April 2004

Study information

• Verified date: April 2005
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 36 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Child Development
• Diarrhea
• Febrile Illness
• Growth
• Pneumonia

Intervention

Drug:
• Micronutrient (Zinc and Iron) fortification

• Pre and Probiotic fortification

Locations

Country	Name	City	State
India	Center for Micronutrient Research	New Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Annamalai University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhea
Primary	Pneumonia
Primary	Febrile illness
Primary	Growth
Primary	Development
Primary	Activity
Secondary	Iron status
Secondary	Zinc status
Secondary	Colonization
Secondary	Copper status