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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02346188
Other study ID # H.22.00.07.06B
Secondary ID
Status Completed
Phase N/A
First received January 20, 2015
Last updated January 23, 2015
Start date January 2000
Est. completion date December 2001

Study information

Verified date January 2015
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

We conducted a 2x2 factorial, placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children in TorreĆ³n, 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.


Recruitment information / eligibility

Status Completed
Enrollment 602
Est. completion date December 2001
Est. primary completion date December 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria:

- 1st grade child

Exclusion Criteria:

- Blood lead concentration =>45 ug/dL

- Hemoglobin concentration < 9 g/dL

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ferrous fumarate
Tablet formulated from 30 mg ferrous fumarate.
Zinc oxide
Tablet formulated from 30 mg zinc oxide
Placebo


Locations

Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health National Institute of Medical Sciences and Nutrition, Salvador Zubiran, National Polytechnic Institute, Mexico

Country where clinical trial is conducted

United States, 

References & Publications (9)

Kordas K, Canfield RL, López P, Rosado JL, Vargas GG, Cebrián 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. Epub 200 — View Citation

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):105-1 — View Citation

Kordas K, Lopez P, Rosado JL, García Vargas G, Alatorre Rico J, Ronquillo D, Cebrián 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 — View Citation

Kordas K, Stoltzfus RJ, López 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. — View Citation

Moodie S, Ialongo N, López P, Rosado J, García-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;34:3 — View Citation

Rico JA, Kordas K, López 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): — View Citation

Rosado JL, López P, Kordas K, García-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. — View Citation

Rosado JL, Ronquillo D, Kordas K, Rojas O, Alatorre J, Lopez P, Garcia-Vargas G, Del Carmen Caamaño M, Cebrián ME, Stoltzfus RJ. Arsenic exposure and cognitive performance in Mexican schoolchildren. Environ Health Perspect. 2007 Sep;115(9):1371-5. — View Citation

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 Torreón, Mexico. Environ Res. 2011 Jul;111(5):670-6. doi: 10.1016/j.envres.2011.03.003. Epub — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Arsenic exposure total urinary arsenic, inorganic arsenic, monomethylarsonic acid, dimethylarsinic acid 6-12 months No
Primary Blood lead concentration 6-12 months No
Secondary Anthropometric composite Height, weight 6-12 months No
Secondary Serum ferritin concentration 6-12 months No
Secondary Serum zinc concentration 6-12 months No
Secondary Hemoglobin concentration 6-12 months No
Secondary Conners Behavior Rating Scales for parents and teachers 6-12 months No
Secondary Peabody Picture Vocabulary Test, Math achievement test, tests of attention and memory 6-12 months No
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