Clinical trial NCT01415557: Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: micronutrient
healthy children
vitamins
minerals
cognition
physical performance
iron
Micronutrient status
Cognitive Performance
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. John's Research Institute
First posted: 2011-08-12
Enrollment: 227
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the micronutrient status in the study subjects at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in cognitive performance at 6 months
timeFrame: 6 months
measure: Change from baseline in the physical performance at 6 months
timeFrame: 6 months
measure: Change from baseline in the fatigue score at 6 months
timeFrame: Baseline and Endline (six months)
measure: Morbidity Assessment
timeFrame: 6 months
measure: Prevalence of Micronutrient Deficiency
timeFrame: 6 months
measure: Change from baseline in anthropometric scores at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St. Johns Research Institute
state: Karnataka
Study officials:
affiliation: St. John's Research Institute
name: Prashanth Thankachan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuriyan R, Thankachan P, Selvam S, Pauline M, Srinivasan K, Kamath-Jha S, Vinoy S, Misra S, Finnegan Y, Kurpad AV. The effects of regular consumption of a multiple micronutrient fortified milk beverage on the micronutrient status of school children and on their mental and physical performance. Clin Nutr. 2016 Feb;35(1):190-198. doi: 10.1016/j.clnu.2015.02.001. Epub 2015 Feb 21.