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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01415557
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : November 7, 2013
Sponsor:
Collaborator:
St. John's Research Institute
Information provided by (Responsible Party):
Mondelēz International, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Other: Non-Fortified Control Product Other: Micronutrient Fortified Test Product Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2012
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415557


Locations
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India
St. Johns Research Institute
Bangalore, Karnataka, India, 560034
Sponsors and Collaborators
Mondelēz International, Inc.
St. John's Research Institute
Investigators
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Principal Investigator: Prashanth Thankachan, PhD St. John's Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01415557    
Other Study ID Numbers: KFTSJRI2011
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013
Keywords provided by Mondelēz International, Inc.:
micronutrient
healthy children
vitamins
minerals
cognition
 physical performance
iron
Micronutrient status
Cognitive Performance
Additional relevant MeSH terms:
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Micronutrients
Trace Elements
Physiological Effects of Drugs