Child Development Clinical Trial
Official 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
To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary
allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period
of one year in comparison to same yoghurt without fortification for change in mean levels
and proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum
transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc
(Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in
cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile
illness), hospitalizations and morbidity causing absenteeism from school and improvement in
growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified
yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not
receive any intervention in the improvement in cognitive development and physical growth.
The main objective is to evaluate the impact of addition of micronutrients to Yoghurt and
can be best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for
that the investigators have included a concurrent control.
Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron,
zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status
indicators, cognitive development, and growth and reduce morbidity of children.
Status | Recruiting |
Enrollment | 1325 |
Est. completion date | August 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 9 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Bangladesh | Department of Community Medicine, SZMC | Bogra |
Lead Sponsor | Collaborator |
---|---|
Annamalai University | Department of Community Medicine SZMC, Bogra Bangladesh, GAIN, Johns Hopkins Bloomberg School of Public Health |
Bangladesh,
Grantham-McGregor SM, Ani CC. The role of micronutrients in psychomotor and cognitive development. Br Med Bull. 1999;55(3):511-27. Review. — View Citation
Winichagoon P, McKenzie JE, Chavasit V, Pongcharoen T, Gowachirapant S, Boonpraderm A, Manger MS, Bailey KB, Wasantwisut E, Gibson RS. A multimicronutrient-fortified seasoning powder enhances the hemoglobin, zinc, and iodine status of primary school children in North East Thailand: a randomized controlled trial of efficacy. J Nutr. 2006 Jun;136(6):1617-23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity | 0 months, 6 months, 12 months | No | |
Primary | Growth | 0 months, 6 months, 12 months | No | |
Primary | Development | 0 months, 6 months, 12 months | No | |
Primary | School performance | 0 months, 6 months, 12 months | No | |
Primary | Status Indicators for iron, zinc, vitamin A and iodine | 0 months, 6 months, 12 months | No |
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