Cognitive PerformanceNCT01491581
Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam
A study testing food bar in people with Cognitive Performance, run by Institut de Recherche pour le Developpement at 1 site in Vietnam.
Trial summary
The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- food bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 2011to Oct 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pupil in one of the 2 selected schools, in grade 1 - 3
- weight for height > -3 z-scores
- hemoglobin concentration > 70 g/L
Who cannot join
- weight for height < -3 z-scores
- hemoglobin concentration <= 70 g/L
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive performances.
Read the detailed description
Design: double-masked randomized control trial Place: three schools in South Vietnam, Can Tho district, South Vietnam Subjects: School children aged 6 to 10 years old, from first grade to third grade of 3 primary schools.
Duration of intervention: 6 months (consumption of Goody or "control bar")
Study groups: 2 groups:
Group 1: children will receive micronutrient enriched milk bar. Group 2: children will receive the same milk-based food except for the micronutrient fortification.
- Conditions
- Cognitive Performance
- Being tested
- food bar
- Keywords
- anthropometry, zinc, iodine, vitamin D, calcium, school children, food supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food barDietary supplement
Also called Goody
milk based food bar enriched with micronutrients
| Study group | Role | What they receive |
|---|---|---|
| micronutrient enriched bar | Experimental | bar enriched with micronutrients Receives: Dietary Supplement: food bar |
| control arm | Placebo comparator | normal bar Receives: Dietary Supplement: food bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
micronutrient status
change in micronutrient status (hemoglobin and serum concentrations of vitamin D, calium, zinc) from baseline to end of the intervention when children have received the food bar for 6 months, 5 days/week.
Measured: 6 months intervention study with baseline and endpoint data collection
Secondary outcomes (1)
cognitive function
change in cognitive function (as measured by Raven's test) in children from baseline to end point, when the children have received 6 months of food bar, 5 days/week
Measured: 6 months intervention study with baseline and endpoint data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Can Tho University, National Institute of Nutrition, Vietnam, Global Alliance for Improved Nutrition, ILSI, Japan
- Responsible party
- Principal investigator, Frank Wieringa, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491581
- Sponsor's protocol ID
- VietnamSchoolBar_2011
- Status last verified
- Nov 2012
- First submitted
- 28 Nov 2011
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam
- ClinicalTrials.gov ID
- NCT01491581
- Acronym / sponsor ID
- VietnamSchoolBar_2011
- Conditions
- Cognitive Performance
- Keywords
- anthropometry, zinc, iodine, vitamin D, calcium, school children, food supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Can Tho University, National Institute of Nutrition, Vietnam, Global Alliance for Improved Nutrition, ILSI, Japan
- Study start
- Dec 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Dec 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 objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive performances.
Detailed description
Design: double-masked randomized control trial Place: three schools in South Vietnam, Can Tho district, South Vietnam Subjects: School children aged 6 to 10 years old, from first grade to third grade of 3 primary schools.
Duration of intervention: 6 months (consumption of Goody or "control bar")
Study groups: 2 groups:
Group 1: children will receive micronutrient enriched milk bar. Group 2: children will receive the same milk-based food except for the micronutrient fortification.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micronutrient enriched bar | Experimental | Dietary Supplement: food barbar enriched with micronutrients |
| control arm | Placebo comparator | Dietary Supplement: food barnormal bar |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- pupil in one of the 2 selected schools, in grade 1 - 3
- weight for height > -3 z-scores
- hemoglobin concentration > 70 g/L
Key exclusion criteria (2 listed)
- weight for height < -3 z-scores
- hemoglobin concentration <= 70 g/L
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 |
|---|---|---|
| food barAlso: Goodymilk based food bar enriched with micronutrients | Dietary supplement | control arm, micronutrient enriched bar |
Primary outcome
micronutrient status
Time frame: 6 months intervention study with baseline and endpoint data collection
change in micronutrient status (hemoglobin and serum concentrations of vitamin D, calium, zinc) from baseline to end of the intervention when children have received the food bar for 6 months, 5 days/week.
1 secondary outcome
cognitive function
Time frame: 6 months intervention study with baseline and endpoint data collection
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 21 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food bar in people with Cognitive Performance, run by Institut de Recherche pour le Developpement at 1 site in Vietnam.
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 3 inclusion and 2 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 21 Nov 2012. 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 Vietnam. 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?
micronutrient status (time frame: 6 months intervention study with baseline and endpoint data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.