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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Non-Fortified Control Product; Other: Micronutrient Fortified Test Product

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: St. John's Research Institute
• Investigators: Principal Investigator: Prashanth Thankachan, PhD, St. John's Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 22, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: cognition; physical performance; iron; vitamins; healthy children; Cognitive Performance; minerals; micronutrient; Micronutrient status
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: KFTSJRI2011