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

The Effects of Regular Consumption of a Multiple Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren and on Their Mental and Physical Performance

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01415557

Enrollment

227

Registered

2011-08-12

Start date

2011-08-31

Completion date

2012-09-30

Last updated

2013-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

micronutrient, healthy children, vitamins, minerals, cognition, physical performance, iron, Micronutrient status, Cognitive Performance

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.

Interventions

OTHERNon-Fortified Control Product

Non-Fortified Control Beverage

OTHERMicronutrient Fortified Test Product

Micronutrient Fortified Test Beverage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

7 Years to 10 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.
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
Morbidity Assessment	6 months	Morbidity will be recorded on a weekly basis from the start until the end of the intervention

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026