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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00980733
Date of registration: 18/09/2009
Primary sponsor: Annamalai University
Public title: Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
Scientific title: Efficacy of Consumption of Micronutrient Fortified Yoghurt on Biochemical Markers, Cognitive Development, Morbidity and Physical Growth Among 6-9 Years School Going Children in Bangladesh - A Double Masked, Randomized Trial With a Concurrent Matched Control
Date of first enrolment: September 2008
Target sample size: 1325
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00980733
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- children aged between 6 to 9 yrs of age,

- enrolled in the school,

- not severely malnourished requiring rehabilitation and micronutrient supplement, AND

- consent to participate.

Inclusion is only based on age and locale: 6-9 years in Gabtali schools and both genders
will be enrolled.

Exclusion Criteria:

- children who are severely malnourished and requiring hospitalization.



Age minimum: 6 Years
Age maximum: 9 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Child Development
Cognitive Development
Morbidity
Physical Growth
Intervention(s)
Dietary Supplement: Fortified Yoghurt
Dietary Supplement: Yoghurt
Primary Outcome(s)
Development [Time Frame: 0 months, 6 months, 12 months]
Growth [Time Frame: 0 months, 6 months, 12 months]
Morbidity [Time Frame: 0 months, 6 months, 12 months]
School performance [Time Frame: 0 months, 6 months, 12 months]
Status Indicators for iron, zinc, vitamin A and iodine [Time Frame: 0 months, 6 months, 12 months]
Secondary Outcome(s)
Secondary ID(s)
Global Alliance G#102512
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Department of Community Medicine SZMC, Bogra Bangladesh
GAIN
Johns Hopkins Bloomberg School of Public Health
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