NCT02346188

Brief Summary

Lead is negatively linked to nutritional status, behavior and cognition in children. Despite extensive knowledge of its toxicity and efforts to reduce exposure, lead continues to be a problem in developed and developing countries. When lead exposure is unavoidable due to its pervasive nature, effective means of protecting or disrupting that exposure need to be developed. Nutritional interventions are one such option. We conducted a 2x2 factorial, placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children in Torreón, Mexico (altitude 1060 m). Nine schools were selected based on proximity to a lead smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30 mg zinc, both, or placebo. In addition to biochemical indicators, cognitive functions and behavior were evaluated at baseline, after the 6-month supplementation period, and again after another 6 months (without supplementation). At baseline, 602 children ages 6.2-8.5 years were enrolled.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
13.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 20, 2015

Last Update Submit

January 23, 2015

Conditions

Lead Poisoning

Keywords

blood lead, iron, zinc, child, cognition, behavior, Mexico

Outcome Measures

Primary Outcomes (1)

  • Blood lead concentration

    6-12 months

Secondary Outcomes (6)

  • Anthropometric composite

    6-12 months

  • Serum ferritin concentration

    6-12 months

  • Serum zinc concentration

    6-12 months

  • Hemoglobin concentration

    6-12 months

  • Conners Behavior Rating Scales for parents and teachers

    6-12 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Arsenic exposure

    6-12 months

Study Arms (4)

Ferrous fumarate

EXPERIMENTAL

Tablet formulated as ferrous fumarate, 30 mg. Given once daily for 6 months.

Dietary Supplement: Ferrous fumarate

Zinc oxide

EXPERIMENTAL

Tablet formulated as zinc oxide, 30 mg. Given once daily by mouth for 6 months.

Dietary Supplement: Zinc oxide

Ferrous fumarate and zinc oxide

EXPERIMENTAL

Tablet, formulated as ferrous fumarate 30 mg plus zinc oxide 30 mg. Given once daily by mouth for 6 months.

Dietary Supplement: Ferrous fumarateDietary Supplement: Zinc oxide

Placebo

PLACEBO COMPARATOR

Sugar tablet formulated to look like the experimental arms of the study. Given daily by mouth for 6 months.

Dietary Supplement: Placebo

Interventions

Ferrous fumarateDIETARY_SUPPLEMENT

Tablet formulated from 30 mg ferrous fumarate.

Ferrous fumarateFerrous fumarate and zinc oxide
Zinc oxideDIETARY_SUPPLEMENT

Tablet formulated from 30 mg zinc oxide

Ferrous fumarate and zinc oxideZinc oxide
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • st grade child

You may not qualify if:

  • Blood lead concentration =\>45 ug/dL
  • Hemoglobin concentration \< 9 g/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (10)

  • Kordas K, Lopez P, Rosado JL, Garcia Vargas G, Alatorre Rico J, Ronquillo D, Cebrian ME, Stoltzfus RJ. Blood lead, anemia, and short stature are independently associated with cognitive performance in Mexican school children. J Nutr. 2004 Feb;134(2):363-71. doi: 10.1093/jn/134.2.363.

    PMID: 14747673RESULT

  • Kordas K, Canfield RL, Lopez P, Rosado JL, Vargas GG, Cebrian ME, Rico JA, Ronquillo D, Stoltzfus RJ. Deficits in cognitive function and achievement in Mexican first-graders with low blood lead concentrations. Environ Res. 2006 Mar;100(3):371-86. doi: 10.1016/j.envres.2005.07.007. Epub 2005 Sep 19.

    PMID: 16169549RESULT

  • Kordas K, Stoltzfus RJ, Lopez P, Rico JA, Rosado JL. Iron and zinc supplementation does not improve parent or teacher ratings of behavior in first grade Mexican children exposed to lead. J Pediatr. 2005 Nov;147(5):632-9. doi: 10.1016/j.jpeds.2005.06.037.

    PMID: 16291354RESULT

  • Rico JA, Kordas K, Lopez P, Rosado JL, Vargas GG, Ronquillo D, Stoltzfus RJ. Efficacy of iron and/or zinc supplementation on cognitive performance of lead-exposed Mexican schoolchildren: a randomized, placebo-controlled trial. Pediatrics. 2006 Mar;117(3):e518-27. doi: 10.1542/peds.2005-1172.

    PMID: 16510631RESULT

  • Rosado JL, Lopez P, Kordas K, Garcia-Vargas G, Ronquillo D, Alatorre J, Stoltzfus RJ. Iron and/or zinc supplementation did not reduce blood lead concentrations in children in a randomized, placebo-controlled trial. J Nutr. 2006 Sep;136(9):2378-83. doi: 10.1093/jn/136.9.2378.

    PMID: 16920858RESULT

  • Rosado JL, Ronquillo D, Kordas K, Rojas O, Alatorre J, Lopez P, Garcia-Vargas G, Del Carmen Caamano M, Cebrian ME, Stoltzfus RJ. Arsenic exposure and cognitive performance in Mexican schoolchildren. Environ Health Perspect. 2007 Sep;115(9):1371-5. doi: 10.1289/ehp.9961.

    PMID: 17805430RESULT

  • Kordas K, Casavantes KM, Mendoza C, Lopez P, Ronquillo D, Rosado JL, Vargas GG, Stoltzfus RJ. The association between lead and micronutrient status, and children's sleep, classroom behavior, and activity. Arch Environ Occup Health. 2007 Summer;62(2):105-12. doi: 10.3200/AEOH.62.2.105-112.

    PMID: 18316268RESULT

  • Roy A, Kordas K, Lopez P, Rosado JL, Cebrian ME, Vargas GG, Ronquillo D, Stoltzfus RJ. Association between arsenic exposure and behavior among first-graders from Torreon, Mexico. Environ Res. 2011 Jul;111(5):670-6. doi: 10.1016/j.envres.2011.03.003. Epub 2011 Mar 25.

    PMID: 21439564RESULT

  • Moodie S, Ialongo N, Lopez P, Rosado J, Garcia-Vargas G, Ronquillo D, Kordas K. The conjoint influence of home enriched environment and lead exposure on children's cognition and behaviour in a Mexican lead smelter community. Neurotoxicology. 2013 Jan;34:33-41. doi: 10.1016/j.neuro.2012.10.004. Epub 2012 Oct 27.

    PMID: 23110976RESULT

  • Kordas K, Roy A, Lopez P, Garcia-Vargas G, Cebrian ME, Vera-Aguilar E, Rosado JL. Iron and Zinc Supplementation Does Not Impact Urinary Arsenic Excretion in Mexican School Children. J Pediatr. 2017 Jun;185:205-210.e1. doi: 10.1016/j.jpeds.2017.02.040. Epub 2017 Mar 23.

    PMID: 28343659DERIVED

MeSH Terms

Conditions

Lead PoisoningBehavior

Interventions

ferrous fumarateZinc Oxide

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

OxidesOxygen CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Rebecca J Stoltzfus, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

January 1, 2000

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

US(1)