Vitamin A DeficiencyEarly Phase 1NCT01061307
An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
A Early Phase 1 study testing fortified extruded rice in people with Vitamin A Deficiency and Iron Deficiency, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
Trial summary
Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
- What is being tested?
- fortified extruded rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2009to Jun 2010
- Phase
- Early Phase 1
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preliminary screening: 650 children of 7-12 y-old children attending the primary school serving a low-income area in Muang district , Satun.(no exclusion criteria).
- Efficacy trial: 180-200 children, children with the Zn deficiency (serum zinc < 65, 66 and 70 µg/dL in children < 10y, male ≥ 10y and female ≥ 10y)
Who cannot join
- Children showing severe iron, zinc or vitamin A deficiency. These children will be excluded from the study and treated according to local policies.
- Significant chronic medical illness, including gastrointestinal, hematological, hepatic or renal disorders.
- Low school attendance (<80%).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
Swiss Federal Institute of Technology Zurich
Zurich, 8092
Thailand1 site
Institute of Nutrition Mahidol University
Phuttamonthon, Changwat Nakhon Pathom, 73170
About this study
Official title: An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand
Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies.
Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.
In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.
- Conditions
- Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
- Being tested
- fortified extruded rice
- Keywords
- Fe deficiency, Zn deficiency, vitamin A deficiency
- Medical subject headings
- Vitamin A Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified extruded riceDietary supplement
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
| Study group | Role | What they receive |
|---|---|---|
| fortified extruded rice | Experimental | fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice Receives: Dietary Supplement: fortified extruded rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Zn
Measured: September 2009-March 2010
Hemoglobin
Measured: September 2009-2010
serum retinol
Measured: September 2009-March 2010
serum ferritin
Measured: September 2009-March 2010
ZPP
Measured: September 2009- March 2010
Secondary outcomes (1)
Anthropometry measures
Measured: September 2009-March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061307
- Sponsor's protocol ID
- ETH2010/1
- Status last verified
- Apr 2012
- First submitted
- 2 Feb 2010
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.
PubMed 26447158Pinkaew S, Winichagoon P, Hurrell RF, Wegmuller R. Extruded rice grains fortified with zinc, iron, and vitamin A increase zinc status of Thai school children when incorporated into a school lunch program. J Nutr. 2013 Mar;143(3):362-8. doi: 10.3945/jn.112.166058. Epub 2013 Jan 9.
PubMed 23303870
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand
- ClinicalTrials.gov ID
- NCT01061307
- Acronym / sponsor ID
- ETH2010/1
- Conditions
- Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
- Keywords
- Fe deficiency, Zn deficiency, vitamin A deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Feb 2010 (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.
Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies.
Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.
In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fortified extruded rice | Experimental | Dietary Supplement: fortified extruded ricefortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preliminary screening: 650 children of 7-12 y-old children attending the primary school serving a low-income area in Muang district , Satun.(no exclusion criteria).
- Efficacy trial: 180-200 children, children with the Zn deficiency (serum zinc < 65, 66 and 70 µg/dL in children < 10y, male ≥ 10y and female ≥ 10y)
Key exclusion criteria (3 listed)
- Children showing severe iron, zinc or vitamin A deficiency. These children will be excluded from the study and treated according to local policies.
- Significant chronic medical illness, including gastrointestinal, hematological, hepatic or renal disorders.
- Low school attendance (<80%).
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 extruded ricefortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice | Dietary supplement | fortified extruded rice |
Primary outcome
serum Zn
Time frame: September 2009-March 2010
Hemoglobin
Time frame: September 2009-2010
serum retinol
Time frame: September 2009-March 2010
serum ferritin
Time frame: September 2009-March 2010
ZPP
Time frame: September 2009- March 2010
1 secondary outcome
Anthropometry measures
Time frame: September 2009-March 2010
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 6 Jan 2016.
- Derived from this study: PubMed 26447158Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.
- Derived from this study: PubMed 23303870Pinkaew S, Winichagoon P, Hurrell RF, Wegmuller R. Extruded rice grains fortified with zinc, iron, and vitamin A increase zinc status of Thai school children when incorporated into a school lunch program. J Nutr. 2013 Mar;143(3):362-8. doi: 10.3945/jn.112.166058. Epub 2013 Jan 9.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing fortified extruded rice in people with Vitamin A Deficiency and Iron Deficiency, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
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 2 inclusion and 3 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
serum Zn (time frame: September 2009-March 2010). 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 NCT01061307, which also lists 2 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 6 Jan 2016.