NCT00255385

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

Completed Phase 3 Last updated 16 November 2005

What this trial tests

Phase 3 trial testing Micronutrient (Zinc and Iron) fortification in Diarrhea in 1,200 participants. Completed in 1 April 2004.

Timeline

1 April 2002

1 April 2004

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,200
Start date	1 April 2002
Estimated completion	1 April 2004
Sites	1 location across India

Drugs / interventions tested

• Micronutrient (Zinc and Iron) fortification — full drug profile →
• Pre and Probiotic fortification — full drug profile →

Conditions studied

• Diarrhea — all drugs for Diarrhea →
• Pneumonia — all drugs for Pneumonia →
• Febrile Illness — all drugs for Febrile Illness →
• Growth — all drugs for Growth →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Adults 12 Months to 36 Months, any sex, with Diarrhea or Pneumonia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Diarrhea
• Pneumonia
• Febrile illness
• Growth
• Development
• Activity

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Micronutrient fortified milk improves iron status, anemia and growth among children 1-4 years: a double masked, randomized, controlled trial.
   Sazawal S, Dhingra U, Dhingra P, Hiremath G, et al · · 2010 · cited 64× · PMID 20730057 · DOI 10.1371/journal.pone.0012167
2. Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial.
   Sazawal S, Dhingra U, Hiremath G, Sarkar A, et al · · 2010 · cited 56× · PMID 20730056 · DOI 10.1371/journal.pone.0012164
3. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial.
   Sazawal S, Dhingra U, Dhingra P, Hiremath G, et al · · 2007 · cited 50× · PMID 17132678 · DOI 10.1136/bmj.39035.482396.55
4. Efficiency of red cell distribution width in identification of children aged 1-3 years with iron deficiency anemia against traditional hematological markers.
   Sazawal S, Dhingra U, Dhingra P, Dutta A, et al · · 2014 · cited 18× · PMID 24428927 · DOI 10.1186/1471-2431-14-8
5. Interventions to prevent obesity in children aged 2 to 4 years old.
   Phillips SM, Spiga F, Moore TH, Dawson S, et al · · 2025 · cited 3× · PMID 40494564 · DOI 10.1002/14651858.cd015326.pub2