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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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
Fe, Zn, Fe+Zn, Placebo
placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IQ score
Time Frame: Aug 2007-Jan 2008
Aug 2007-Jan 2008

Secondary Outcome Measures

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

Mahidol University

Collaborators

Emory University
Nevin Scrimshaw International Nutrition Foundation

Investigators

  • 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

July 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID 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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