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

NCT ID: NCT01415557

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Healthy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Non-Fortified Control Product

Non-fortified control beverage

Group Type PLACEBO_COMPARATOR

Non-Fortified Control Product

Intervention Type OTHER

Non-Fortified Control Beverage

Micronutrient Fortified Test Product

Micronutrient fortified test beverage

Group Type ACTIVE_COMPARATOR

Micronutrient Fortified Test Product

Intervention Type OTHER

Micronutrient Fortified Test Beverage

Interventions

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Non-Fortified Control Product

Non-Fortified Control Beverage

Intervention Type OTHER

Micronutrient Fortified Test Product

Micronutrient Fortified Test Beverage

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. John's Research Institute

OTHER

Sponsor Role collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prashanth Thankachan, PhD

Role: PRINCIPAL_INVESTIGATOR

St. John's Research Institute

Locations

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St. Johns Research Institute

Bangalore, Karnataka, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 25746819 (View on PubMed)

Other Identifiers

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KFTSJRI2011

Identifier Type: -

Identifier Source: org_study_id