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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Non-Fortified Control Product; Other: Micronutrient Fortified Test Product

• Registration Number: NCT01415557
• Lead Sponsor: Mondelēz International, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-22
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2012-03
• Study Completion: 2012-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Fortified Control Product	Non-Fortified Control Product	Non-fortified control beverage
Micronutrient Fortified Test Product	Micronutrient Fortified Test Product	Micronutrient fortified test beverage

Primary Outcome Measures

Name	Time	Method
Change from baseline in the micronutrient status in the study subjects at 6 months	6 months	The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in cognitive performance at 6 months	6 months	Change from baseline in cognitive test scores at the end of the intervention for all subjects.
Change from baseline in the physical performance at 6 months	6 months	Change from baseline in the physical test scores at end of intervention for all subjects
Change from baseline in the fatigue score at 6 months	Baseline and Endline (six months)	Change from baseline in the fatigue score at end of intervention for all subjects
Morbidity Assessment	6 months	Morbidity will be recorded on a weekly basis from the start until the end of the intervention
Prevalence of Micronutrient Deficiency	6 months	Prevalence of micronutrient deficiency in each study arm at the end the intervention
Change from baseline in anthropometric scores at 6 months	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

Trial Locations

Locations (1)

St. Johns Research Institute; 🇮🇳 Bangalore, Karnataka, India