Clinical trial NCT00824304: Long-term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth
Official title: Long-Term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth 8 Years Later: A Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Function
Growth
Keywords: cognitive performance
growth
iron
zinc
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Nevin Scrimshaw International Nutrition Foundation
name: Emory University
First posted: 2009-01-16
Enrollment: 562
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All available children who received iron and zinc study during infancy

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Neurological disorder

Primary outcomes:
measure: IQ score
timeFrame: Aug 2007-Jan 2008
Secondary outcomes:
measure: Anthropometry status
timeFrame: Aug 2007-Jan 2008
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Ubonrat, Nampong, and Banphang district
Study officials:
affiliation: Nutrition and Health Sciences Program, Emory University
name: Tippawan Pongcharoen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubert Department of Global Health, Emory University
name: Reynaldo Martorell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Pattanee Winichagoon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.