Cognitive FunctionFeZn_FUNCT00824304
Long-term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth
An observational study of Cognitive Function and Growth, run by Mahidol University at 1 site in Thailand.
Trial summary
The hypotheses of this study are: 1. Compared to children who received a placebo, children who received iron or zinc or iron and zinc combined will perform better on cognitive tests and will have better growth status at ages 8 to 10 years. 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Growth
- How many people
- 562 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2007to Jul 2009
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All available children who received iron and zinc study during infancy
Who may be able to join
- All available children who received iron and zinc study during infancy
Who cannot join
- Neurological disorder
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ubonrat, Nampong, and Banphang district
Khon Kaen, Changwat Khon Kaen, 40250
About this study
Official title: Long-Term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth 8 Years Later: A Follow-Up Study
The hypotheses of this study are:
- Compared to children who received a placebo, children who received iron or zinc or iron and zinc combined will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
- Compared to children who received iron or zinc alone, children who received iron and zinc combined will perform differently on cognitive tests and will have different growth status at 8 ages 8 to 10 years
- Compared to children who had poorer iron and zinc status or poorer growth status before and after supplementation during infancy, children who had better iron and zinc status or better growth status before and after supplementation during infancy will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
- Compared to children who have lower iron and zinc status, poorer growth status, or low animal source intake at ages 8 to 10 years, children who have higher iron and zinc status, better growth status, or high animal source intake at ages 8 to 10 years will perform better on cognitive tests and will have better growth status.
Read the detailed description
Iron and zinc are important micronutrients for cognitive development and growth in children, particularly during infancy when brain development and physical growth are rapid. Iron and zinc deficiencies likely coexist in young children in poor developing countries due to high requirements for these micronutrients at this age, low consumption of animal products (which are rich sources of these nutrients) and similar problems of poor bioavailability from plant foods. One would expect that iron and zinc supplementation in infancy would be an appropriate strategy to promote long-term cognitive development and school achievement, but this has never been evaluated. We have many studies of the effects on micronutrient interventions in infancy but the benefits of these interventions have been assessed only in terms of outcomes in infancy. What are missing are studies of micronutrient interventions during the critical phase of infancy that report effects measured in school children and beyond. Only then will we begin to understand the full impact of micronutrient interventions in infancy on human function. From 1998 to 1999, a randomized, placebo controlled trial of iron and zinc supplementation was carried out in 609 4-6 month-old infants in Khon Kaen province, Thailand. Infants were randomized to four groups (zinc, iron, iron and zinc, placebo) and those supplemented received 10 mg of iron and/or 10 mg of zinc daily for 6 months. Improvements in iron and zinc status and in ponderal growth were found; no measures of cognitive development in infancy were included. We propose a follow-up study of these children at ages 8 to 10 years. From February to July 2006, we conducted a pilot study and were able to locate 584 or 96% of the sample. The children are all in school and we propose to assess schooling, cognitive performance (Wechsler test adapted to Thailand) and language and mathematical skills. In addition, data on physical growth, biochemical status, dietary intakes and socioeconomic status will be collected. We expect that knowledge from this study will be useful for properly assessing the full benefits of improving iron and zinc status in early childhood.
- Conditions
- Cognitive Function, Growth
- Keywords
- cognitive performance, growth, iron, zinc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fe, Zn, Fe+Zn, Placebo | placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
IQ score
Measured: Aug 2007-Jan 2008
Secondary outcomes (1)
Anthropometry status
Measured: Aug 2007-Jan 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJul 2009
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 Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Nevin Scrimshaw International Nutrition Foundation, Emory University
- Responsible party
- Sponsor
- Investigators
- Tippawan Pongcharoen, M.Sc., Principal investigator, Nutrition and Health Sciences Program, Emory UniversityReynaldo Martorell, Ph.D., Principal investigator, Hubert Department of Global Health, Emory UniversityPattanee Winichagoon, Ph.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824304
- Sponsor's protocol ID
- MU 2007-121
- Other IDs
- IRB00003440
- Acronym
- FeZn_FU
- Status last verified
- Jan 2009
- First submitted
- 14 Jan 2009
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pongcharoen T, DiGirolamo AM, Ramakrishnan U, Winichagoon P, Flores R, Martorell R. Long-term effects of iron and zinc supplementation during infancy on cognitive function at 9 y of age in northeast Thai children: a follow-up study. Am J Clin Nutr. 2011 Mar;93(3):636-43. doi: 10.3945/ajcn.110.002220. Epub 2011 Jan 26.
PubMed 21270383
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth 8 Years Later: A Follow-Up Study
- ClinicalTrials.gov ID
- NCT00824304
- Acronym / sponsor ID
- FeZn_FU / MU 2007-121
- Conditions
- Cognitive Function, Growth
- Keywords
- cognitive performance, growth, iron, zinc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Nevin Scrimshaw International Nutrition Foundation, Emory University
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Jan 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.
The hypotheses of this study are:
- Compared to children who received a placebo, children who received iron or zinc or iron and zinc combined will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
- Compared to children who received iron or zinc alone, children who received iron and zinc combined will perform differently on cognitive tests and will have different growth status at 8 ages 8 to 10 years
- Compared to children who had poorer iron and zinc status or poorer growth status before and after supplementation during infancy, children who had better iron and zinc status or better growth status before and after supplementation during infancy will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
- Compared to children who have lower iron and zinc status, poorer growth status, or low animal source intake at ages 8 to 10 years, children who have higher iron and zinc status, better growth status, or high animal source intake at ages 8 to 10 years will perform better on cognitive tests and will have better growth status.
Detailed description
Iron and zinc are important micronutrients for cognitive development and growth in children, particularly during infancy when brain development and physical growth are rapid. Iron and zinc deficiencies likely coexist in young children in poor developing countries due to high requirements for these micronutrients at this age, low consumption of animal products (which are rich sources of these nutrients) and similar problems of poor bioavailability from plant foods. One would expect that iron and zinc supplementation in infancy would be an appropriate strategy to promote long-term cognitive development and school achievement, but this has never been evaluated. We have many studies of the effects on micronutrient interventions in infancy but the benefits of these interventions have been assessed only in terms of outcomes in infancy. What are missing are studies of micronutrient interventions during the critical phase of infancy that report effects measured in school children and beyond. Only then will we begin to understand the full impact of micronutrient interventions in infancy on human function. From 1998 to 1999, a randomized, placebo controlled trial of iron and zinc supplementation was carried out in 609 4-6 month-old infants in Khon Kaen province, Thailand. Infants were randomized to four groups (zinc, iron, iron and zinc, placebo) and those supplemented received 10 mg of iron and/or 10 mg of zinc daily for 6 months. Improvements in iron and zinc status and in ponderal growth were found; no measures of cognitive development in infancy were included. We propose a follow-up study of these children at ages 8 to 10 years. From February to July 2006, we conducted a pilot study and were able to locate 584 or 96% of the sample. The children are all in school and we propose to assess schooling, cognitive performance (Wechsler test adapted to Thailand) and language and mathematical skills. In addition, data on physical growth, biochemical status, dietary intakes and socioeconomic status will be collected. We expect that knowledge from this study will be useful for properly assessing the full benefits of improving iron and zinc status in early childhood.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fe, Zn, Fe+Zn, Placebo | – | –placebo comparator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All available children who received iron and zinc study during infancy
Key inclusion criteria (1 listed)
- All available children who received iron and zinc study during infancy
Key exclusion criteria (1 listed)
- Neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IQ score
Time frame: Aug 2007-Jan 2008
1 secondary outcome
Anthropometry status
Time frame: Aug 2007-Jan 2008
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 18 Feb 2013.
- Derived from this study: PubMed 21270383Pongcharoen T, DiGirolamo AM, Ramakrishnan U, Winichagoon P, Flores R, Martorell R. Long-term effects of iron and zinc supplementation during infancy on cognitive function at 9 y of age in northeast Thai children: a follow-up study. Am J Clin Nutr. 2011 Mar;93(3):636-43. doi: 10.3945/ajcn.110.002220. Epub 2011 Jan 26.
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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.
Tippawan Pongcharoen, M.Sc. principal investigator
Nutrition and Health Sciences Program, Emory University
Reynaldo Martorell, Ph.D. principal investigator
Hubert Department of Global Health, Emory University
Pattanee Winichagoon, Ph.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Function and Growth, run by Mahidol University 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 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: finished, as of the sponsor's last update on 18 Feb 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 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.
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?
IQ score (time frame: Aug 2007-Jan 2008). 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 NCT00824304, 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 18 Feb 2013.