Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren

Mondelēz International, Inc.227 enrolled

Overview

The purpose of this study is to assess the impact of regular consumption of micronutrient fortified drink in improving nutritional and micronutrient status in Indian school children. The test beverage will be fortified with both, vitamins and minerals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

227

Conditions

Healthy

Interventions

Non-Fortified Control ProductOTHER

Non-Fortified Control Beverage

Micronutrient Fortified Test ProductOTHER

Micronutrient Fortified Test Beverage

Eligibility

Sex: ALLMin age: 7 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Apparently healthy school going children * not severely malnourished weight-for-height z-score ≥-2 not severely anemic (Hb\<8g/dl) * Age: 7-10 years * Not taking any food supplements/fortified drinks * Not planning to move out during the study duration Exclusion Criteria: * Age: \<7 and \>10 years * Severe anemia (Hb \< 8 g/dl) * Severely malnourished children with weight-for-height z-score \<-3 will be excluded. * Cardiovascular disease on clinical examination or history * Underlying respiratory disease with impairment of lung function * Physical disability which can interfere or limit performance of tests * Recent history (3 months prior) of serious infections, injuries and/ or surgeries * Any food allergy or food intolerance * Participation in any nutritional study in the last 1year * Children consuming nutritional supplements and/ or health food drinks

Locations (1)

St. Johns Research Institute

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

Change from baseline in the micronutrient status in the study subjects at 6 months

The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.

Time frame: 6 months

Secondary Outcomes

Change from baseline in cognitive performance at 6 months

Change from baseline in cognitive test scores at the end of the intervention for all subjects.

Time frame: 6 months

Change from baseline in the physical performance at 6 months

Change from baseline in the physical test scores at end of intervention for all subjects

Time frame: 6 months

Change from baseline in the fatigue score at 6 months

Change from baseline in the fatigue score at end of intervention for all subjects

Time frame: Baseline and Endline (six months)

Morbidity Assessment

Morbidity will be recorded on a weekly basis from the start until the end of the intervention

Time frame: 6 months

Prevalence of Micronutrient Deficiency

Prevalence of micronutrient deficiency in each study arm at the end the intervention

Time frame: 6 months

Change from baseline in anthropometric scores at 6 months

Change from baseline in anthropometric measures (Standardized (WHO, 2007) weight for age, height for age and BMI for age of the study subjects) at the end of the intervention

Time frame: 6 months

Data from ClinicalTrials.gov

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