NCT02346188

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

Effects of Iron and Zinc Supplementation on Neuropsychological and Educational Achievement in Lead-exposed School Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

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.

Detailed description

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) to test the hypothesis that supplementation with iron, zinc or both will reduce blood lead concentrations of the children and improve their cognition and behavior. 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 (blood lead, serum ferritin, CRP, serum zinc, urinary arsenic concentrations), cognitive functions and behavior were measured. Assessments were conducted at three time points: at baseline, after the 6 month treatment, and again after another 6 months without treatment. At baseline, 602 children ages 6.2-8.5 years were enrolled.

Conditions

• Lead Poisoning

Interventions

Type	Name	Description
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

Timeline

• Start date: 2000-01-01
• Primary completion: 2001-12-01
• Completion: 2001-12-01
• First posted: 2015-01-26
• Last updated: 2015-01-26

Locations

1 site across 1 country: United States