HealthyNCT01415557
Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren
A study testing Micronutrient Fortified Test Product in people with Healthy, run by Mondelēz International, Inc. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Micronutrient Fortified Test Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Non-Fortified Control Product, Micronutrient Fortified Test Product
- Keywords
- micronutrient, healthy children, vitamins, minerals, cognition, physical performance, iron, Micronutrient status, Cognitive Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Fortified Control ProductOther
Non-Fortified Control Beverage
Micronutrient Fortified Test ProductOther
Micronutrient Fortified Test Beverage
| Study group | Role | What they receive |
|---|---|---|
| Non-Fortified Control Product | Placebo comparator | Non-fortified control beverage Receives: Other: Non-Fortified Control Product |
| Micronutrient Fortified Test Product | Active comparator | Micronutrient fortified test beverage Receives: Other: Micronutrient Fortified Test Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the micronutrient status in the study subjects at 6 months
The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.
Measured: 6 months
Secondary outcomes (6)
Change from baseline in cognitive performance at 6 months
Change from baseline in cognitive test scores at the end of the intervention for all subjects.
Measured: 6 months
Change from baseline in the physical performance at 6 months
Change from baseline in the physical test scores at end of intervention for all subjects
Measured: 6 months
Change from baseline in the fatigue score at 6 months
Change from baseline in the fatigue score at end of intervention for all subjects
Measured: Baseline and Endline (six months)
Morbidity Assessment
Morbidity will be recorded on a weekly basis from the start until the end of the intervention
Measured: 6 months
Prevalence of Micronutrient Deficiency
Prevalence of micronutrient deficiency in each study arm at the end the intervention
Measured: 6 months
Change from baseline in anthropometric scores at 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. John's Research Institute
- Responsible party
- Sponsor
- Investigators
- Prashanth Thankachan, PhD, Principal investigator, St. John's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415557
- Sponsor's protocol ID
- KFTSJRI2011
- Status last verified
- Nov 2013
- First submitted
- 22 Jul 2011
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuriyan R, Thankachan P, Selvam S, Pauline M, Srinivasan K, Kamath-Jha S, Vinoy S, Misra S, Finnegan Y, Kurpad AV. The effects of regular consumption of a multiple micronutrient fortified milk beverage on the micronutrient status of school children and on their mental and physical performance. Clin Nutr. 2016 Feb;35(1):190-198. doi: 10.1016/j.clnu.2015.02.001. Epub 2015 Feb 21.
PubMed 25746819
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01415557
- Acronym / sponsor ID
- KFTSJRI2011
- Conditions
- Healthy
- Keywords
- micronutrient, healthy children, vitamins, minerals, cognition, physical performance, iron, Micronutrient status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. John's Research Institute
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Fortified Control Product | Placebo comparator | Other: Non-Fortified Control ProductNon-fortified control beverage |
| Micronutrient Fortified Test Product | Active comparator | Other: Micronutrient Fortified Test ProductMicronutrient fortified test beverage |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Fortified Control ProductNon-Fortified Control Beverage | Other | Non-Fortified Control Product |
| Micronutrient Fortified Test ProductMicronutrient Fortified Test Beverage | Other | Micronutrient Fortified Test Product |
Primary outcome
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.
6 secondary outcomes
Change from baseline in cognitive performance at 6 months
Time frame: 6 months
Change from baseline in the physical performance at 6 months
Time frame: 6 months
Change from baseline in the fatigue score at 6 months
Time frame: Baseline and Endline (six months)
Morbidity Assessment
Time frame: 6 months
Prevalence of Micronutrient Deficiency
Time frame: 6 months
Change from baseline in anthropometric scores at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
- Derived from this study: PubMed 25746819Kuriyan R, Thankachan P, Selvam S, Pauline M, Srinivasan K, Kamath-Jha S, Vinoy S, Misra S, Finnegan Y, Kurpad AV. The effects of regular consumption of a multiple micronutrient fortified milk beverage on the micronutrient status of school children and on their mental and physical performance. Clin Nutr. 2016 Feb;35(1):190-198. doi: 10.1016/j.clnu.2015.02.001. Epub 2015 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashanth Thankachan, PhD principal investigator
St. John's Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrient Fortified Test Product in people with Healthy, run by Mondelēz International, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the micronutrient status in the study subjects at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.