CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 602 enrolled
Drug / intervention
Ferrous fumarate +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02346188
NCT02346188N/ACompleted

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

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jan 26, 2015·Updated Jan 26, 2015

In Brief

A clinical study evaluating Ferrous fumarate, Zinc oxide, and 1 other intervention for Lead Poisoning. Completed, enrolled 602 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLead Poisoning
CountriesUnited States

Timeline

N/ACompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 26, 2015
Enrollment StartJan 1, 2000
Primary CompletionDec 1, 2001
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.4 years ago

Interventions

Ferrous fumaratedietary

Tablet formulated from 30 mg ferrous fumarate.

Zinc oxidedietary

Tablet formulated from 30 mg zinc oxide

Placebodietary