Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
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
1 other identifier
interventional
1,325
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2009
CompletedFirst Posted
Study publicly available on registry
September 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 21, 2009
September 1, 2009
1.6 years
September 18, 2009
September 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Morbidity
0 months, 6 months, 12 months
Growth
0 months, 6 months, 12 months
Development
0 months, 6 months, 12 months
School performance
0 months, 6 months, 12 months
Status Indicators for iron, zinc, vitamin A and iodine
0 months, 6 months, 12 months
Study Arms (3)
Fortified Yoghurt
ACTIVE COMPARATORYoghurt with fortification of Micronutrients, yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate.
Yoghurt
PLACEBO COMPARATORPlain Yoghurt same as in fortified arm but without fortification
Control
NO INTERVENTIONNon blinded group given no intervention
Interventions
The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- children who are severely malnourished and requiring hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Annamalai Universitylead
- Johns Hopkins Bloomberg School of Public Healthcollaborator
- Department of Community Medicine SZMC, Bogra Bangladeshcollaborator
- Global Alliance for Improved Nutritioncollaborator
Study Sites (1)
Department of Community Medicine, SZMC
Bogra, Bangladesh
Related Publications (3)
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. doi: 10.1093/jn/136.6.1617.
PMID: 16702330BACKGROUNDGrantham-McGregor SM, Ani CC. The role of micronutrients in psychomotor and cognitive development. Br Med Bull. 1999;55(3):511-27. doi: 10.1258/0007142991902583.
PMID: 10746342BACKGROUNDSazawal S, Habib A, Dhingra U, Dutta A, Dhingra P, Sarkar A, Deb S, Alam J, Husna A, Black RE. Impact of micronutrient fortification of yoghurt on micronutrient status markers and growth - a randomized double blind controlled trial among school children in Bangladesh. BMC Public Health. 2013 May 28;13:514. doi: 10.1186/1471-2458-13-514.
PMID: 23714325DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 18, 2009
First Posted
September 21, 2009
Study Start
September 1, 2008
Primary Completion
April 1, 2010
Study Completion
August 1, 2010
Last Updated
September 21, 2009
Record last verified: 2009-09