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

This study has been completed.
Sponsor:
Collaborators:
International Nutrition Foundation
Emory University
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT00824304
First received: January 14, 2009
Last updated: February 14, 2013
Last verified: January 2009
  Purpose

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.

Condition
Cognitive Function
Growth

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Long-Term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth 8 Years Later: A Follow-Up Study

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • IQ score [ Time Frame: Aug 2007-Jan 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometry status [ Time Frame: Aug 2007-Jan 2008 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and urine


Enrollment: 562
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fe, Zn, Fe+Zn, Placebo
placebo comparator

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All available children who received iron and zinc study during infancy

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurological disorder
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00824304

Locations
Thailand
Ubonrat, Nampong, and Banphang district
Khon Kaen, Thailand, 40250
Sponsors and Collaborators
Mahidol University
International Nutrition Foundation
Emory University
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
  More Information

No publications provided by Mahidol University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT00824304     History of Changes
Other Study ID Numbers: MU 2007-121, IRB00003440
Study First Received: January 14, 2009
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mahidol University:
cognitive performance
growth
iron
zinc

ClinicalTrials.gov processed this record on August 28, 2014