Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
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.
Description
Study population: Children aged 6-9 years both boys and girls from 6 primary schools of Gabtali town of Bogra district in Bangladesh.
Sample Size: 1200 children (400 in each group) Enrollment of eligible children and Base line information: Details of all eligible children will be obtained from the schools to be a part of the study and their parents will be contacted for an appointment either by telephone or sending a note. Consent for participation will be sought after evaluating inclusion and exclusion criteria and will be randomized to receive either fortified or non fortified yoghurt, similarly consent will be obtained from the parents of children from the non yoghurt area who will not be given any intervention. Baseline information on socioeconomic information, retrospective morbidity information of the child for the last 15 days, hospitalization, hygiene and sanitation information will be recorded. Baseline clinical assessments and anthropometric measurements will be conducted. 5 ml of venous blood sample (approx. one spoonful of blood) and mid stream urine sample will be obtained by a trained nurse/technician employed by the project. Developmental assessments measuring children's intelligence and executive functioning (WISC, KCPT, WCST) will be conducted using standardized tests. Blood/urine sampling will not be done for the children in the pure control group (no intervention).
Randomization and blinding: Randomization schedule will be drawn using randomization by permuted blocks of fixed length which is appropriate for double blind studies.
Intervention and Follow-up: For the yoghurt group, the intervention would be supplied in a disposable 80 g cup. Computer labels will be generated on a daily basis with identification information and the allocated code printed on it for all the enrolled children in the database and the appropriate yoghurt cups will be labeled for each child. The labeled yoghurt cups will be then handed over to the school supervisor to deliver to the student in his/her supervision during lunch break of the school. Children will receive the intervention for a period of 12 months. Children from the matched control in the non-yoghurt area will not receive any intervention.
Mid Study data collection: Similar to the baseline, anthropometric measurements will be done and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and mid study. Blood/urine sampling will not be done for children in the pure control.
End Study data collection: An end study similar to the baseline, anthropometric measurements will be taken and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and end study. Blood/urine sampling will not be done for the children in the pure control (no intervention group). Detailed developmental assessments using a battery of computerized neuropsychological (CANTAB) and cognition tests (WISC, K-CPT and WCST) will be conducted. Academic achievement will be assessed using school report cards.
Intervention Groups: There will be one study group with one control group. Both the groups would receive yoghurt in a 80 g cup. The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Child Development
Intervention
Fortified Yoghurt, Yoghurt
Location
Department of Community Medicine, SZMC
Bogra
Bangladesh
Status
Recruiting
Source
Annamalai University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00980733
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Food, Fortified
Any food that has been supplemented with essential nutrients either in quantities that are greater than those present normally, or which are not present in the fortified food. The supplementation of cereals with iron and vitamins is an example of fortified food. Fortified food includes also enriched food to which various nutrients have been added to compensate for those essential nutrients removed by refinement or processing. (From Segen, Dictionary of Modern Medicine, 1992)
Child, Exceptional
A child whose needs, abilities, or other characteristics vary so much from the average in mental, physical, or social areas that a greater than usual level of services is needed to facilitate the child's maximum potential development.
Child Language
The language and sounds expressed by a child at a particular maturational stage in development.
Child Development Disorders, Pervasive
Severe distortions in the development of many basic psychological functions that are not normal for any stage in development. These distortions are manifested in sustained social impairment, speech abnormalities, and peculiar motor movements.
Parenting
Performing the role of a parent by care-giving, nurturance, and protection of the child by a natural or substitute parent. The parent supports the child by exercising authority and through consistent, empathic, appropriate behavior in response to the child's needs. PARENTING differs from CHILD REARING in that in child rearing the emphasis is on the act of training or bringing up the children and the interaction between the parent and child, while parenting emphasizes the responsibility and qualities of exemplary behavior of the parent.
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