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

This study has been completed.

Sponsor:

Collaborator:

St. John's Research Institute

Information provided by (Responsible Party):

Mondelēz International, Inc.

ClinicalTrials.gov Identifier:

NCT01415557

First received: July 22, 2011

Last updated: November 5, 2013

Last verified: November 2013

History of Changes

Purpose

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.

Condition	Intervention
Healthy	Other: Non-Fortified Control Product Other: Micronutrient Fortified Test Product


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
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

Further study details as provided by Mondelēz International, Inc.:

Primary Outcome Measures:

Change from baseline in the micronutrient status in the study subjects at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.

Secondary Outcome Measures:

Change from baseline in cognitive performance at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Endline (six months) ] [ Designated as safety issue: No ]
Change from baseline in the fatigue score at end of intervention for all subjects
Morbidity Assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Morbidity will be recorded on a weekly basis from the start until the end of the intervention
Prevalence of Micronutrient Deficiency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Prevalence of micronutrient deficiency in each study arm at the end the intervention
Change from baseline in anthropometric scores at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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


Enrollment:	227
Study Start Date:	August 2011
Study Completion Date:	September 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Non-Fortified Control Product Non-fortified control beverage	Other: Non-Fortified Control Product Non-Fortified Control Beverage
Active Comparator: Micronutrient Fortified Test Product Micronutrient fortified test beverage	Other: Micronutrient Fortified Test Product Micronutrient Fortified Test Beverage

Eligibility


Ages Eligible for Study:	7 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415557

Locations


India
St. Johns Research Institute
Bangalore, Karnataka, India, 560034

Sponsors and Collaborators

Mondelēz International, Inc.

St. John's Research Institute

Investigators


Principal Investigator:	Prashanth Thankachan, PhD	St. John's Research Institute

More Information

No publications provided


Responsible Party:	Mondelēz International, Inc.
ClinicalTrials.gov Identifier:	NCT01415557 History of Changes
Other Study ID Numbers:	KFTSJRI2011
Study First Received:	July 22, 2011
Last Updated:	November 5, 2013
Health Authority:	India: Institutional Review Board

Keywords provided by Mondelēz International, Inc.:


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

Additional relevant MeSH terms:


Micronutrients Trace Elements Growth Substances Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015

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