Child DevelopmentPhase 3NCT00980733
Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
A Phase 3 study testing Fortified Yoghurt and Yoghurt in people with Child Development and Cognitive Development, run by Annamalai University at 1 site in Bangladesh.
Trial summary
To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year in comparison to same yoghurt without fortification for change in mean levels and proportion deficient for markers of status… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Child Development, Cognitive Development, Morbidity
- What is being tested?
- Fortified Yoghurt and Yoghurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,325 participants
- Where
- 1 siteBangladesh
- Study dates
- Sep 2008to Aug 2010
- Phase
- Phase 3
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged between 6 to 9 yrs of age,
- enrolled in the school,
- not severely malnourished requiring rehabilitation and micronutrient supplement, AND
- consent to participate.
- Inclusion is only based on age and locale: 6-9 years in Gabtali schools and both genders will be enrolled.
Who cannot join
- children who are severely malnourished and requiring hospitalization.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Department of Community Medicine, SZMC
Bogura
Ahsan Habib, MD, 880-1712062050, drakmnannu@yahoo.com
Sunil Sazawal, MD, PhD, 91-11-41724901, ssazawal@jhsph.edu
About this study
Official title: Efficacy of Consumption of Micronutrient Fortified Yoghurt on Biochemical Markers, Cognitive Development, Morbidity and Physical Growth Among 6-9 Years School Going Children in Bangladesh - A Double Masked, Randomized Trial With a Concurrent Matched Control
To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year in comparison to same yoghurt without fortification for change in mean levels and proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc (Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile illness), hospitalizations and morbidity causing absenteeism from school and improvement in growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not receive any intervention in the improvement in cognitive development and physical growth. The main objective is to evaluate the impact of addition of micronutrients to Yoghurt and can be best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for that the investigators have included a concurrent control.
Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status indicators, cognitive development, and growth and reduce morbidity of children.
Read the detailed description
Study population: Children aged 6-9 years both boys and girls from 6 primary schools of Gabtali town of Bogra district in Bangladesh.
Sample Size: 1200 children (400 in each group) Enrollment of eligible children and Base line information: Details of all eligible children will be obtained from the schools to be a part of the study and their parents will be contacted for an appointment either by telephone or sending a note. Consent for participation will be sought after evaluating inclusion and exclusion criteria and will be randomized to receive either fortified or non fortified yoghurt, similarly consent will be obtained from the parents of children from the non yoghurt area who will not be given any intervention. Baseline information on socioeconomic information, retrospective morbidity information of the child for the last 15 days, hospitalization, hygiene and sanitation information will be recorded. Baseline clinical assessments and anthropometric measurements will be conducted. 5 ml of venous blood sample (approx. one spoonful of blood) and mid stream urine sample will be obtained by a trained nurse/technician employed by the project. Developmental assessments measuring children's intelligence and executive functioning (WISC, KCPT, WCST) will be conducted using standardized tests. Blood/urine sampling will not be done for the children in the pure control group (no intervention).
Randomization and blinding: Randomization schedule will be drawn using randomization by permuted blocks of fixed length which is appropriate for double blind studies.
Intervention and Follow-up: For the yoghurt group, the intervention would be supplied in a disposable 80 g cup. Computer labels will be generated on a daily basis with identification information and the allocated code printed on it for all the enrolled children in the database and the appropriate yoghurt cups will be labeled for each child. The labeled yoghurt cups will be then handed over to the school supervisor to deliver to the student in his/her supervision during lunch break of the school. Children will receive the intervention for a period of 12 months. Children from the matched control in the non-yoghurt area will not receive any intervention.
Mid Study data collection: Similar to the baseline, anthropometric measurements will be done and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and mid study. Blood/urine sampling will not be done for children in the pure control.
End Study data collection: An end study similar to the baseline, anthropometric measurements will be taken and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and end study. Blood/urine sampling will not be done for the children in the pure control (no intervention group). Detailed developmental assessments using a battery of computerized neuropsychological (CANTAB) and cognition tests (WISC, K-CPT and WCST) will be conducted. Academic achievement will be assessed using school report cards.
Intervention Groups: There will be one study group with one control group. Both the groups would receive yoghurt in a 80 g cup. The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine.
- Conditions
- Child Development, Cognitive Development, Morbidity, Physical Growth
- Being tested
- Fortified Yoghurt, Yoghurt
- Keywords
- Micronutrients, zinc, iron, iodine, fortification, school children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified YoghurtDietary supplement
The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate.
YoghurtDietary supplement
Plain yoghurt same as in intervention group without fortification
| Study group | Role | What they receive |
|---|---|---|
| Fortified Yoghurt | Active comparator | Yoghurt with fortification of Micronutrients, yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate. Receives: Dietary Supplement: Fortified Yoghurt |
| Yoghurt | Placebo comparator | Plain Yoghurt same as in fortified arm but without fortification Receives: Dietary Supplement: Yoghurt |
| Control | No intervention | Non blinded group given no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Measured: 0 months, 6 months, 12 months
Growth
Measured: 0 months, 6 months, 12 months
Development
Measured: 0 months, 6 months, 12 months
School performance
Measured: 0 months, 6 months, 12 months
Status Indicators for iron, zinc, vitamin A and iodine
Measured: 0 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annamalai University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Department of Community Medicine SZMC, Bogra Bangladesh, Global Alliance for Improved Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980733
- Sponsor's protocol ID
- Global Alliance G#102512
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winichagoon P, McKenzie JE, Chavasit V, Pongcharoen T, Gowachirapant S, Boonpraderm A, Manger MS, Bailey KB, Wasantwisut E, Gibson RS. A multimicronutrient-fortified seasoning powder enhances the hemoglobin, zinc, and iodine status of primary school children in North East Thailand: a randomized controlled trial of efficacy. J Nutr. 2006 Jun;136(6):1617-23. doi: 10.1093/jn/136.6.1617.
PubMed 16702330Grantham-McGregor SM, Ani CC. The role of micronutrients in psychomotor and cognitive development. Br Med Bull. 1999;55(3):511-27. doi: 10.1258/0007142991902583.
PubMed 10746342Sazawal S, Habib A, Dhingra U, Dutta A, Dhingra P, Sarkar A, Deb S, Alam J, Husna A, Black RE. Impact of micronutrient fortification of yoghurt on micronutrient status markers and growth - a randomized double blind controlled trial among school children in Bangladesh. BMC Public Health. 2013 May 28;13:514. doi: 10.1186/1471-2458-13-514.
PubMed 23714325
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Consumption of Micronutrient Fortified Yoghurt on Biochemical Markers, Cognitive Development, Morbidity and Physical Growth Among 6-9 Years School Going Children in Bangladesh - A Double Masked, Randomized Trial With a Concurrent Matched Control
- ClinicalTrials.gov ID
- NCT00980733
- Acronym / sponsor ID
- Global Alliance G#102512
- Conditions
- Child Development, Cognitive Development, Morbidity, Physical Growth
- Keywords
- Micronutrients, zinc, iron, iodine, fortification, school children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,325 participants (estimated)
- Lead sponsor
- Annamalai UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Department of Community Medicine SZMC, Bogra Bangladesh, Global Alliance for Improved Nutrition
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 21 Sep 2009 (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.
To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year in comparison to same yoghurt without fortification for change in mean levels and proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc (Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile illness), hospitalizations and morbidity causing absenteeism from school and improvement in growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not receive any intervention in the improvement in cognitive development and physical growth. The main objective is to evaluate the impact of addition of micronutrients to Yoghurt and can be best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for that the investigators have included a concurrent control.
Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status indicators, cognitive development, and growth and reduce morbidity of children.
Detailed description
Study population: Children aged 6-9 years both boys and girls from 6 primary schools of Gabtali town of Bogra district in Bangladesh.
Sample Size: 1200 children (400 in each group) Enrollment of eligible children and Base line information: Details of all eligible children will be obtained from the schools to be a part of the study and their parents will be contacted for an appointment either by telephone or sending a note. Consent for participation will be sought after evaluating inclusion and exclusion criteria and will be randomized to receive either fortified or non fortified yoghurt, similarly consent will be obtained from the parents of children from the non yoghurt area who will not be given any intervention. Baseline information on socioeconomic information, retrospective morbidity information of the child for the last 15 days, hospitalization, hygiene and sanitation information will be recorded. Baseline clinical assessments and anthropometric measurements will be conducted. 5 ml of venous blood sample (approx. one spoonful of blood) and mid stream urine sample will be obtained by a trained nurse/technician employed by the project. Developmental assessments measuring children's intelligence and executive functioning (WISC, KCPT, WCST) will be conducted using standardized tests. Blood/urine sampling will not be done for the children in the pure control group (no intervention).
Randomization and blinding: Randomization schedule will be drawn using randomization by permuted blocks of fixed length which is appropriate for double blind studies.
Intervention and Follow-up: For the yoghurt group, the intervention would be supplied in a disposable 80 g cup. Computer labels will be generated on a daily basis with identification information and the allocated code printed on it for all the enrolled children in the database and the appropriate yoghurt cups will be labeled for each child. The labeled yoghurt cups will be then handed over to the school supervisor to deliver to the student in his/her supervision during lunch break of the school. Children will receive the intervention for a period of 12 months. Children from the matched control in the non-yoghurt area will not receive any intervention.
Mid Study data collection: Similar to the baseline, anthropometric measurements will be done and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and mid study. Blood/urine sampling will not be done for children in the pure control.
End Study data collection: An end study similar to the baseline, anthropometric measurements will be taken and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and end study. Blood/urine sampling will not be done for the children in the pure control (no intervention group). Detailed developmental assessments using a battery of computerized neuropsychological (CANTAB) and cognition tests (WISC, K-CPT and WCST) will be conducted. Academic achievement will be assessed using school report cards.
Intervention Groups: There will be one study group with one control group. Both the groups would receive yoghurt in a 80 g cup. The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fortified Yoghurt | Active comparator | Dietary Supplement: Fortified YoghurtYoghurt with fortification of Micronutrients, yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate. |
| Yoghurt | Placebo comparator | Dietary Supplement: YoghurtPlain Yoghurt same as in fortified arm but without fortification |
| Control | No intervention | –Non blinded group given no intervention |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children aged between 6 to 9 yrs of age,
- enrolled in the school,
- not severely malnourished requiring rehabilitation and micronutrient supplement, AND
- consent to participate.
- Inclusion is only based on age and locale: 6-9 years in Gabtali schools and both genders will be enrolled.
Key exclusion criteria (1 listed)
- children who are severely malnourished and requiring hospitalization.
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 |
|---|---|---|
| Fortified YoghurtThe study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate. | Dietary supplement | Fortified Yoghurt |
| YoghurtPlain yoghurt same as in intervention group without fortification | Dietary supplement | Yoghurt |
Primary outcome
Morbidity
Time frame: 0 months, 6 months, 12 months
Growth
Time frame: 0 months, 6 months, 12 months
Development
Time frame: 0 months, 6 months, 12 months
School performance
Time frame: 0 months, 6 months, 12 months
Status Indicators for iron, zinc, vitamin A and iodine
Time frame: 0 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
- Background: PubMed 16702330Winichagoon P, McKenzie JE, Chavasit V, Pongcharoen T, Gowachirapant S, Boonpraderm A, Manger MS, Bailey KB, Wasantwisut E, Gibson RS. A multimicronutrient-fortified seasoning powder enhances the hemoglobin, zinc, and iodine status of primary school children in North East Thailand: a randomized controlled trial of efficacy. J Nutr. 2006 Jun;136(6):1617-23. doi: 10.1093/jn/136.6.1617.
- Background: PubMed 10746342Grantham-McGregor SM, Ani CC. The role of micronutrients in psychomotor and cognitive development. Br Med Bull. 1999;55(3):511-27. doi: 10.1258/0007142991902583.
- Derived from this study: PubMed 23714325Sazawal S, Habib A, Dhingra U, Dutta A, Dhingra P, Sarkar A, Deb S, Alam J, Husna A, Black RE. Impact of micronutrient fortification of yoghurt on micronutrient status markers and growth - a randomized double blind controlled trial among school children in Bangladesh. BMC Public Health. 2013 May 28;13:514. doi: 10.1186/1471-2458-13-514.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fortified Yoghurt and Yoghurt in people with Child Development and Cognitive Development, run by Annamalai University at 1 site in Bangladesh.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2009. 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 Bangladesh. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sunil Sazawal, MD, PhD (91-11-41724901, ssazawal@jhsph.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 0 months, 6 months, 12 months). The study lists 5 primary outcomes in all. 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 NCT00980733, which also lists 3 linked publications.
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 Sep 2009.