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

M

Mondelez International

Status

Completed

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01415557
KFTSJRI2011

Details and patient eligibility

About

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.

Enrollment

227 patients

Sex

All

Ages

7 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

227 participants in 2 patient groups, including a placebo group

Non-Fortified Control Product
Placebo Comparator group
Description:
Non-fortified control beverage
Treatment:
Other: Non-Fortified Control Product
Micronutrient Fortified Test Product
Active Comparator group
Description:
Micronutrient fortified test beverage
Treatment:
Other: Micronutrient Fortified Test Product

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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