An interventional study of Ferrous fumarate and Zinc oxide in Lead Poisoning, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Treatment
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.
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.
27 studies on the registry are indexed under Lead Poisoning; 2 are open to participants now.
This study's enrollment of 602 is above the median of 175 across 11 interventional studies indexed under Lead Poisoning.
Browse Lead Poisoning studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tablet formulated as ferrous fumarate, 30 mg. Given once daily for 6 months.
Dietary Supplement: Ferrous fumarate
Tablet formulated as zinc oxide, 30 mg. Given once daily by mouth for 6 months.
Dietary Supplement: Zinc oxide
Tablet, formulated as ferrous fumarate 30 mg plus zinc oxide 30 mg. Given once daily by mouth for 6 months.
Dietary Supplement: Ferrous fumarate · Dietary Supplement: Zinc oxide
Sugar tablet formulated to look like the experimental arms of the study. Given daily by mouth for 6 months.
Dietary Supplement: Placebo
Tablet formulated from 30 mg ferrous fumarate.
Tablet formulated from 30 mg zinc oxide
Blood lead concentration
Time frame: 6-12 months
Anthropometric composite
Height, weight
Time frame: 6-12 months
Serum ferritin concentration
Time frame: 6-12 months
Serum zinc concentration
Time frame: 6-12 months
Hemoglobin concentration
Time frame: 6-12 months
Conners Behavior Rating Scales for parents and teachers
Time frame: 6-12 months
Peabody Picture Vocabulary Test, Math achievement test, tests of attention and memory
Time frame: 6-12 months
Arsenic exposure
total urinary arsenic, inorganic arsenic, monomethylarsonic acid, dimethylarsinic acid
Time frame: 6-12 months
The record gives a start of Jan 2000, a primary completion of Dec 2001 and a completion of Dec 2001. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ferrous fumarate · Zinc Oxide
Johns Hopkins Bloomberg School of Public Health →