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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00824304
First Posted: January 16, 2009
Last Update Posted: February 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Nevin Scrimshaw International Nutrition Foundation
Emory University
Information provided by (Responsible Party):
Mahidol University
  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 ]

Secondary Outcome Measures:
  • Anthropometry status [ Time Frame: Aug 2007-Jan 2008 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824304


Locations
Thailand
Ubonrat, Nampong, and Banphang district
Khon Kaen, Thailand, 40250
Sponsors and Collaborators
Mahidol University
Nevin Scrimshaw 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

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
First Submitted: January 14, 2009
First Posted: January 16, 2009
Last Update Posted: February 18, 2013
Last Verified: January 2009

Keywords provided by Mahidol University:
cognitive performance
growth
iron
zinc