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Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead

NCT02346188 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2015-01-26

No results posted yet for this study

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.

Conditions

  • Lead Poisoning

Interventions

DIETARY_SUPPLEMENT

Ferrous fumarate

Tablet formulated from 30 mg ferrous fumarate.

DIETARY_SUPPLEMENT

Zinc oxide

Tablet formulated from 30 mg zinc oxide

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • National Institute of Medical Sciences and Nutrition, Salvador Zubiran

    collaborator OTHER

  • National Polytechnic Institute, Mexico

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Rebecca J Stoltzfus, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2001-12-31
Completion
2001-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346188 on ClinicalTrials.gov