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.

Conditions

• Child Development
• Cognitive Development
• Morbidity
• Physical Growth

Interventions

DIETARY_SUPPLEMENT

Fortified Yoghurt

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.

DIETARY_SUPPLEMENT

Yoghurt

Plain yoghurt same as in intervention group without fortification

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Department of Community Medicine SZMC, Bogra Bangladesh

  collaborator UNKNOWN

• Global Alliance for Improved Nutrition

  collaborator OTHER

• Annamalai University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2010-04-30

Completion

2010-08-31

Countries

• Bangladesh

Study Locations