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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00980733 |
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Date of registration:
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18/09/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
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Scientific title:
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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 |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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1325 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00980733 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Sunil Sazawal, MD, PhD |
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Address:
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Telephone:
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91-11-41724901 |
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Email:
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ssazawal@jhsph.edu |
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Affiliation:
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Name:
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Ahsan Habib, MD |
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Address:
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Telephone:
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880-1712062050 |
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Email:
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drakmnannu@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Cognitive Development
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Physical Growth
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Morbidity
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Child Development
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Intervention(s)
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Dietary Supplement: Fortified Yoghurt
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Dietary Supplement: Yoghurt
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Primary Outcome(s)
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Morbidity
[Time Frame: 0 months, 6 months, 12 months]
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Development
[Time Frame: 0 months, 6 months, 12 months]
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School performance
[Time Frame: 0 months, 6 months, 12 months]
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Status Indicators for iron, zinc, vitamin A and iodine
[Time Frame: 0 months, 6 months, 12 months]
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Growth
[Time Frame: 0 months, 6 months, 12 months]
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Secondary ID(s)
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Global Alliance G#102512
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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