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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2012

Interventions

  • Other: Non-Fortified Control Product
    • Non-Fortified Control Beverage
  • Other: Micronutrient Fortified Test Product
    • Micronutrient Fortified Test Beverage

Arms, Groups and Cohorts

  • Placebo Comparator: Non-Fortified Control Product
    • Non-fortified control beverage
  • Active Comparator: Micronutrient Fortified Test Product
    • Micronutrient fortified test beverage

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from baseline in cognitive performance at 6 months
    • Time Frame: 6 months
    • 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
    • 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)
    • Change from baseline in the fatigue score at end of intervention for all subjects
  • Morbidity Assessment
    • Time Frame: 6 months
    • 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
    • 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
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mondelēz International, Inc.
  • Collaborator
    • St. John’s Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Prashanth Thankachan, PhD, Principal Investigator, St. John’s Research Institute

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