Long-term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth (FeZn_FU)

February 14, 2013 updated by: Mahidol University

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:

  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. 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
  3. 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.
  4. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
562

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40250
        • Ubonrat, Nampong, and Banphang district

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All available children who received iron and zinc study during infancy

Description

Inclusion Criteria:

  • All available children who received iron and zinc study during infancy

Exclusion Criteria:

  • Neurological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Fe, Zn, Fe+Zn, Placebo
placebo comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
IQ score
Time Frame: Aug 2007-Jan 2008
Aug 2007-Jan 2008

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Anthropometry status
Time Frame: Aug 2007-Jan 2008
Aug 2007-Jan 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emory University
Nevin Scrimshaw International Nutrition Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tippawan Pongcharoen, M.Sc., Nutrition and Health Sciences Program, Emory University
  • Principal Investigator: Reynaldo Martorell, Ph.D., Hubert Department of Global Health, Emory University
  • Principal Investigator: Pattanee Winichagoon, Ph.D., Mahidol university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MU 2007-121
  • IRB00003440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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