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Completed

NCT Number: NCT01415557

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

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.

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Key information

Conditions

Healthy

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Johns Research Institute

Bangalore, Karnataka, 560034, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Fortified Control Product

Other

Non-Fortified Control Beverage

Micronutrient Fortified Test Product

Other

Micronutrient Fortified Test Beverage

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. 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

  4. Morbidity Assessment

    Time frame: 6 months

    Morbidity will be recorded on a weekly basis from the start until the end of the intervention

  5. Prevalence of Micronutrient Deficiency

    Time frame: 6 months

    Prevalence of micronutrient deficiency in each study arm at the end the intervention

  6. 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

Sponsors and collaborators

Lead sponsor

Mondelēz International, Inc.

Industry

Collaborators

  • St. John's Research Institute

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2011
Registry last updated
Nov 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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