Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead
Primary Purpose
Lead Poisoning
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ferrous fumarate
Zinc oxide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lead Poisoning focused on measuring blood lead, iron, zinc, child, cognition, behavior, Mexico
Eligibility Criteria
Inclusion Criteria:
- 1st grade child
Exclusion Criteria:
- Blood lead concentration =>45 ug/dL
- Hemoglobin concentration < 9 g/dL
Sites / Locations
- Johns Hopkins Bloomberg School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Ferrous fumarate
Zinc oxide
Ferrous fumarate and zinc oxide
Placebo
Arm Description
Tablet formulated as ferrous fumarate, 30 mg. Given once daily for 6 months.
Tablet formulated as zinc oxide, 30 mg. Given once daily by mouth for 6 months.
Tablet, formulated as ferrous fumarate 30 mg plus zinc oxide 30 mg. Given once daily by mouth for 6 months.
Sugar tablet formulated to look like the experimental arms of the study. Given daily by mouth for 6 months.
Outcomes
Primary Outcome Measures
Blood lead concentration
Secondary Outcome Measures
Anthropometric composite
Height, weight
Serum ferritin concentration
Serum zinc concentration
Hemoglobin concentration
Conners Behavior Rating Scales for parents and teachers
Peabody Picture Vocabulary Test, Math achievement test, tests of attention and memory
Full Information
NCT ID
NCT02346188
First Posted
January 20, 2015
Last Updated
January 23, 2015
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran, National Polytechnic Institute, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT02346188
Brief Title
Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead
Official Title
Effects of Iron and Zinc Supplementation on Neuropsychological and Educational Achievement in Lead-exposed School Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran, National Polytechnic Institute, Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lead Poisoning
Keywords
blood lead, iron, zinc, child, cognition, behavior, Mexico
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
602 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferrous fumarate
Arm Type
Experimental
Arm Description
Tablet formulated as ferrous fumarate, 30 mg. Given once daily for 6 months.
Arm Title
Zinc oxide
Arm Type
Experimental
Arm Description
Tablet formulated as zinc oxide, 30 mg. Given once daily by mouth for 6 months.
Arm Title
Ferrous fumarate and zinc oxide
Arm Type
Experimental
Arm Description
Tablet, formulated as ferrous fumarate 30 mg plus zinc oxide 30 mg. Given once daily by mouth for 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar tablet formulated to look like the experimental arms of the study. Given daily by mouth for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous fumarate
Intervention Description
Tablet formulated from 30 mg ferrous fumarate.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc oxide
Intervention Description
Tablet formulated from 30 mg zinc oxide
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Blood lead concentration
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Anthropometric composite
Description
Height, weight
Time Frame
6-12 months
Title
Serum ferritin concentration
Time Frame
6-12 months
Title
Serum zinc concentration
Time Frame
6-12 months
Title
Hemoglobin concentration
Time Frame
6-12 months
Title
Conners Behavior Rating Scales for parents and teachers
Time Frame
6-12 months
Title
Peabody Picture Vocabulary Test, Math achievement test, tests of attention and memory
Time Frame
6-12 months
Other Pre-specified Outcome Measures:
Title
Arsenic exposure
Description
total urinary arsenic, inorganic arsenic, monomethylarsonic acid, dimethylarsinic acid
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1st grade child
Exclusion Criteria:
Blood lead concentration =>45 ug/dL
Hemoglobin concentration < 9 g/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca J Stoltzfus, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14747673
Citation
Kordas K, Lopez P, Rosado JL, Garcia Vargas G, Alatorre Rico J, Ronquillo D, Cebrian 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. doi: 10.1093/jn/134.2.363.
Results Reference
result
PubMed Identifier
16169549
Citation
Kordas K, Canfield RL, Lopez P, Rosado JL, Vargas GG, Cebrian 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. doi: 10.1016/j.envres.2005.07.007. Epub 2005 Sep 19.
Results Reference
result
PubMed Identifier
16291354
Citation
Kordas K, Stoltzfus RJ, Lopez 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. doi: 10.1016/j.jpeds.2005.06.037.
Results Reference
result
PubMed Identifier
16510631
Citation
Rico JA, Kordas K, Lopez 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):e518-27. doi: 10.1542/peds.2005-1172.
Results Reference
result
PubMed Identifier
16920858
Citation
Rosado JL, Lopez P, Kordas K, Garcia-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. doi: 10.1093/jn/136.9.2378.
Results Reference
result
PubMed Identifier
17805430
Citation
Rosado JL, Ronquillo D, Kordas K, Rojas O, Alatorre J, Lopez P, Garcia-Vargas G, Del Carmen Caamano M, Cebrian ME, Stoltzfus RJ. Arsenic exposure and cognitive performance in Mexican schoolchildren. Environ Health Perspect. 2007 Sep;115(9):1371-5. doi: 10.1289/ehp.9961.
Results Reference
result
PubMed Identifier
18316268
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):105-12. doi: 10.3200/AEOH.62.2.105-112.
Results Reference
result
PubMed Identifier
21439564
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 Torreon, Mexico. Environ Res. 2011 Jul;111(5):670-6. doi: 10.1016/j.envres.2011.03.003. Epub 2011 Mar 25.
Results Reference
result
PubMed Identifier
23110976
Citation
Moodie S, Ialongo N, Lopez P, Rosado J, Garcia-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;34:33-41. doi: 10.1016/j.neuro.2012.10.004. Epub 2012 Oct 27.
Results Reference
result
PubMed Identifier
28343659
Citation
Kordas K, Roy A, Lopez P, Garcia-Vargas G, Cebrian ME, Vera-Aguilar E, Rosado JL. Iron and Zinc Supplementation Does Not Impact Urinary Arsenic Excretion in Mexican School Children. J Pediatr. 2017 Jun;185:205-210.e1. doi: 10.1016/j.jpeds.2017.02.040. Epub 2017 Mar 23.
Results Reference
derived
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Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead
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