NCT00255385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2005

Completed
Last Updated

November 18, 2005

Status Verified

April 1, 2005

First QC Date

November 16, 2005

Last Update Submit

November 16, 2005

Conditions

DiarrheaPneumoniaFebrile IllnessGrowthChild Development

Keywords

ZincIronProbioticsPrebioticsChild healthMilk fortificationRandomized controlled trial

Outcome Measures

Primary Outcomes (6)

  • Diarrhea

  • Pneumonia

  • Febrile illness

  • Growth

  • Development

  • Activity

Secondary Outcomes (4)

  • Iron status

  • Zinc status

  • Colonization

  • Copper status

Interventions

Micronutrient (Zinc and Iron) fortificationDRUG
Pre and Probiotic fortificationDRUG

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Micronutrient Research

New Delhi, New Delhi, 110024, India

Location

Related Publications (4)

  • Sazawal S, Dhingra U, Dhingra P, Dutta A, Shabir H, Menon VP, Black RE. Efficiency of red cell distribution width in identification of children aged 1-3 years with iron deficiency anemia against traditional hematological markers. BMC Pediatr. 2014 Jan 15;14:8. doi: 10.1186/1471-2431-14-8.

    PMID: 24428927DERIVED

  • Sazawal S, Dhingra U, Dhingra P, Hiremath G, Sarkar A, Dutta A, Menon VP, Black RE. Micronutrient fortified milk improves iron status, anemia and growth among children 1-4 years: a double masked, randomized, controlled trial. PLoS One. 2010 Aug 13;5(8):e12167. doi: 10.1371/journal.pone.0012167.

    PMID: 20730057DERIVED

  • Sazawal S, Dhingra U, Hiremath G, Sarkar A, Dhingra P, Dutta A, Verma P, Menon VP, Black RE. Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial. PLoS One. 2010 Aug 13;5(8):e12164. doi: 10.1371/journal.pone.0012164.

    PMID: 20730056DERIVED

  • Sazawal S, Dhingra U, Dhingra P, Hiremath G, Kumar J, Sarkar A, Menon VP, Black RE. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial. BMJ. 2007 Jan 20;334(7585):140. doi: 10.1136/bmj.39035.482396.55. Epub 2006 Nov 28.

    PMID: 17132678DERIVED

MeSH Terms

Conditions

DiarrheaPneumonia

Interventions

MicronutrientsZincIronLead

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 18, 2005

Study Start

April 1, 2002

Study Completion

April 1, 2004

Last Updated

November 18, 2005

Record last verified: 2005-04

Locations

IN(1)