Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren
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ClinicalTrials.gov Identifier: NCT01415557 |
Recruitment Status :
Completed
First Posted : August 12, 2011
Last Update Posted : November 7, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Other: Non-Fortified Control Product Other: Micronutrient Fortified Test Product | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Non-Fortified Control Product
Non-fortified control beverage
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Other: Non-Fortified Control Product
Non-Fortified Control Beverage |
Active Comparator: Micronutrient Fortified Test Product
Micronutrient fortified test beverage
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Other: Micronutrient Fortified Test Product
Micronutrient Fortified Test Beverage |
- 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.
- 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

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Ages Eligible for Study: | 7 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
India | |
St. Johns Research Institute | |
Bangalore, Karnataka, India, 560034 |
Principal Investigator: | Prashanth Thankachan, PhD | St. John's Research Institute |
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 |
micronutrient healthy children vitamins minerals cognition |
physical performance iron Micronutrient status Cognitive Performance |
Micronutrients Trace Elements Physiological Effects of Drugs |