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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
  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

Resource links provided by NLM:


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 November 20, 2014