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

NCT00824304 | Completed

• 2 other identifiers: MU 2007-121IRB00003440
• Study Type: observational
• Target: 562
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses of this study are:

1. 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. 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. 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. 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.

Conditions

Cognitive Function; Growth

Keywords

cognitive performance; growth; iron; zinc

Outcome Measures

Primary Outcomes (1)

• IQ score

  Aug 2007-Jan 2008

Secondary Outcomes (1)

• Anthropometry status

  Aug 2007-Jan 2008

Study Arms (1)

Fe, Zn, Fe+Zn, Placebo

placebo comparator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All available children who received iron and zinc study during infancy

You may qualify if:

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

You may not qualify if:

• Neurological disorder

Sponsors & Collaborators

• Mahidol University: lead
• Nevin Scrimshaw International Nutrition Foundation: collaborator
• Emory University: collaborator

Study Sites (1)

Ubonrat, Nampong, and Banphang district

Khon Kaen, Changwat Khon Kaen, 40250, Thailand

Location

Related Publications (1)

• 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.

  PMID: 21270383 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: July 1, 2009
• Last Updated: February 18, 2013

Record last verified: 2009-01

Locations

TH (1)