HealthyPhase 2NCT00728273
Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children
A Phase 2 study testing worm treatment and multiple micronutrient fortified biscuits in people with Healthy, run by Neys-van Hoogstraten Foundation, The Netherlands at 1 site in Thailand.
Trial summary
The aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- worm treatment and multiple micronutrient fortified biscuits
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2007to Jun 2007
- Phase
- Phase 2
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- school children aged 6-8 years with written informed consent from parents/caregivers
Who cannot join
- hemoglobin concentrations < 80g/L
- chronic disease
- congenital abnormalities
- mental or severe physical handicap
- severe malnutrition
- obesity
- receiving deworming within the previous 6 mo
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Institute of Nutrition, Mahidol University
Nakhon Pathom, 73170
About this study
Official title: Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth in Vietnamese School Children
The aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.
Read the detailed description
Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. The risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. Schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. Food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.
- Conditions
- Healthy
- Being tested
- worm treatment and multiple micronutrient fortified biscuits
- Keywords
- Efficacy, Vietnam, school children, anemia, fortification, micronutrient
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
worm treatment and multiple micronutrient fortified biscuitsDietary supplement
Also called Vidoca (Thephaco, Vietnam)
A single dose of intestinal anthelminthic treatment as orange-flavored chewable tablets containing 400 mg Albendazole (Vidoca, Thephaco, Vietnam) was given. Deworming was repeated with Albendazole for all children at the end of the study (after 4 months).
The composition and amount of nutrients in each serving of fortified biscuit were 6 mg iron, 5.6 mg zinc, 35µg iodine, 300 µg RAE vitamin A, 1.0 mg thiamin, 0.9 mg riboflavin, 1.1 mg vitamin B6, 10.5 mg NE niacin, 1.5 µg vitamin B12, 120 µg folic acid, 28 mg vitamin C, 150 mg calcium, 74 IU vitamin D, 40 mg magnesium, 6.8 µg selenium, 378 mg potassium, 70 mg phosphorus, 3.0 mg pantothenic acid, 2.8 µg vitamin E, 10 µg vitamin K and 18 µg biotin.
| Study group | Role | What they receive |
|---|---|---|
| MMF | Experimental | multi-micronutrient-fortified biscuit plus placebo deworming-treatment Receives: Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits |
| Alb | Experimental | placebo biscuit plus deworming treatment with Albendazole Receives: Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits |
| MMF + Alb | Experimental | multiple micronutrient-fortified biscuits with deworming treatment with Albendazole Receives: Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits |
| placebo | Placebo comparator | placebo biscuit (non-fortified) and placebo deworming treatment Receives: Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement).
Measured: 4 months
Secondary outcomes (2)
growth (especially weight), body composition (body fat)
Measured: 4 months
prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neys-van Hoogstraten Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Investigators
- Pattanee Winichagoon, PhD, Principal investigator, Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728273
- Sponsor's protocol ID
- Neys-code VT 188
- Status last verified
- Nov 2008
- First submitted
- 30 Jul 2008
- Last updated
- 4 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth in Vietnamese School Children
- ClinicalTrials.gov ID
- NCT00728273
- Acronym / sponsor ID
- Neys-code VT 188
- Conditions
- Healthy
- Keywords
- Efficacy, Vietnam, school children, anemia, fortification, micronutrient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Neys-van Hoogstraten Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 5 Aug 2008 (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 aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.
Detailed description
Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. The risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. Schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. Food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MMF | Experimental | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuitsmulti-micronutrient-fortified biscuit plus placebo deworming-treatment |
| Alb | Experimental | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuitsplacebo biscuit plus deworming treatment with Albendazole |
| MMF + Alb | Experimental | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuitsmultiple micronutrient-fortified biscuits with deworming treatment with Albendazole |
| placebo | Placebo comparator | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuitsplacebo biscuit (non-fortified) and placebo deworming treatment |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- school children aged 6-8 years with written informed consent from parents/caregivers
Key exclusion criteria (7 listed)
- hemoglobin concentrations < 80g/L
- chronic disease
- congenital abnormalities
- mental or severe physical handicap
- severe malnutrition
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 |
|---|---|---|
| worm treatment and multiple micronutrient fortified biscuitsAlso: Vidoca (Thephaco, Vietnam)A single dose of intestinal anthelminthic treatment as orange-flavored chewable tablets containing 400 mg Albendazole (Vidoca, Thephaco, Vietnam) was given. Deworming was repeated with Albendazole for all children at the end of the study (after 4 months). The composition and amount of nutrients in each serving of fortified biscuit were 6 mg iron, 5.6 mg zinc, 35µg iodine, 300 µg RAE vitamin A, 1.0 mg thiamin, 0.9 mg riboflavin, 1.1 mg vitamin B6, 10.5 mg NE niacin, 1.5 µg vitamin B12, 120 µg folic acid, 28 mg vitamin C, 150 mg calcium, 74 IU vitamin D, 40 mg magnesium, 6.8 µg selenium, 378 mg potassium, 70 mg phosphorus, 3.0 mg pantothenic acid, 2.8 µg vitamin E, 10 µg vitamin K and 18 µg biotin. | Dietary supplement | Alb, MMF, MMF + Alb, placebo |
Primary outcome
Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement).
Time frame: 4 months
2 secondary outcomes
growth (especially weight), body composition (body fat)
Time frame: 4 months
prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in
Time frame: 4 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 4 Dec 2008.
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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.
Pattanee Winichagoon, PhD principal investigator
Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing worm treatment and multiple micronutrient fortified biscuits in people with Healthy, run by Neys-van Hoogstraten Foundation, The Netherlands at 1 site in Thailand.
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 1 inclusion and 7 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 4 Dec 2008. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement). (time frame: 4 months). 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 4 Dec 2008; AzTrials last refreshed its copy on 7 Nov 2026.