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

NCT ID: NCT00824304

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 562 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-07-31

Brief 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. 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Fe, Zn, Fe+Zn, Placebo

placebo comparator

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Neurological disorder

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nevin Scrimshaw International Nutrition Foundation

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tippawan Pongcharoen, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Nutrition and Health Sciences Program, Emory University

Reynaldo Martorell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hubert Department of Global Health, Emory University

Pattanee Winichagoon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Ubonrat, Nampong, and Banphang district

Khon Kaen, Changwat Khon Kaen, Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 21270383 (View on PubMed)

Other Identifiers

IRB00003440

Identifier Type: -

Identifier Source: secondary_id

MU 2007-121

Identifier Type: -

Identifier Source: org_study_id