Lead PoisoningNCT02346188
Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead
A study testing Ferrous fumarate and Zinc oxide in people with Lead Poisoning, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning
- What is being tested?
- Ferrous fumarate and Zinc oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Dec 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1st grade child
Who cannot join
- Blood lead concentration =>45 ug/dL
- Hemoglobin concentration < 9 g/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Effects of Iron and Zinc Supplementation on Neuropsychological and Educational Achievement in Lead-exposed School Children
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.
Read the 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
- Being tested
- Ferrous fumarate, Zinc oxide, Placebo
- Keywords
- blood lead, iron, zinc, child, cognition, behavior, Mexico
- Medical subject headings
- Lead Poisoning, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous fumarateDietary supplement
Tablet formulated from 30 mg ferrous fumarate.
Zinc oxideDietary supplement
Tablet formulated from 30 mg zinc oxide
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ferrous fumarate | Experimental | Tablet formulated as ferrous fumarate, 30 mg. Given once daily for 6 months. Receives: Dietary Supplement: Ferrous fumarate |
| Zinc oxide | Experimental | Tablet formulated as zinc oxide, 30 mg. Given once daily by mouth for 6 months. Receives: Dietary Supplement: Zinc oxide |
| Ferrous fumarate and zinc oxide | Experimental | Tablet, formulated as ferrous fumarate 30 mg plus zinc oxide 30 mg. Given once daily by mouth for 6 months. Receives: Dietary Supplement: Ferrous fumarate; Dietary Supplement: Zinc oxide |
| Placebo | Placebo comparator | Sugar tablet formulated to look like the experimental arms of the study. Given daily by mouth for 6 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lead concentration
Measured: 6-12 months
Secondary outcomes (6)
Anthropometric composite
Height, weight
Measured: 6-12 months
Serum ferritin concentration
Measured: 6-12 months
Serum zinc concentration
Measured: 6-12 months
Hemoglobin concentration
Measured: 6-12 months
Conners Behavior Rating Scales for parents and teachers
Measured: 6-12 months
Peabody Picture Vocabulary Test, Math achievement test, tests of attention and memory
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2000
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lead PoisoningStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran, National Polytechnic Institute, Mexico
- Responsible party
- Sponsor
- Investigators
- Rebecca J Stoltzfus, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346188
- Sponsor's protocol ID
- H.22.00.07.06B
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14747673Kordas 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.
PubMed 16169549Kordas 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.
PubMed 16291354Rico 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.
PubMed 16510631Rosado 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.
PubMed 16920858Rosado 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.
PubMed 17805430Kordas 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.
PubMed 18316268Roy 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.
PubMed 21439564Moodie 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.
PubMed 23110976Kordas 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.
PubMed 28343659
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iron and Zinc Supplementation on Neuropsychological and Educational Achievement in Lead-exposed School Children
- ClinicalTrials.gov ID
- NCT02346188
- Acronym / sponsor ID
- H.22.00.07.06B
- Conditions
- Lead Poisoning
- Keywords
- blood lead, iron, zinc, child, cognition, behavior, Mexico
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran, National Polytechnic Institute, Mexico
- Study start
- Jan 2000
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ferrous fumarate | Experimental | Dietary Supplement: Ferrous fumarateTablet formulated as ferrous fumarate, 30 mg. Given once daily for 6 months. |
| Zinc oxide | Experimental | Dietary Supplement: Zinc oxideTablet formulated as zinc oxide, 30 mg. Given once daily by mouth for 6 months. |
| Ferrous fumarate and zinc oxide | Experimental | Dietary Supplement: Ferrous fumarate, Dietary Supplement: Zinc oxideTablet, formulated as ferrous fumarate 30 mg plus zinc oxide 30 mg. Given once daily by mouth for 6 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSugar tablet formulated to look like the experimental arms of the study. Given daily by mouth for 6 months. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1st grade child
Key exclusion criteria (2 listed)
- Blood lead concentration =>45 ug/dL
- Hemoglobin concentration < 9 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous fumarateTablet formulated from 30 mg ferrous fumarate. | Dietary supplement | Ferrous fumarate, Ferrous fumarate and zinc oxide |
| Zinc oxideTablet formulated from 30 mg zinc oxide | Dietary supplement | Ferrous fumarate and zinc oxide, Zinc oxide |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Blood lead concentration
Time frame: 6-12 months
6 secondary outcomes
Anthropometric composite
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Results publication: PubMed 14747673Kordas 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 publication: PubMed 16169549Kordas 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 publication: PubMed 16291354Kordas 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 publication: PubMed 16510631Rico 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 publication: PubMed 16920858Rosado 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 publication: PubMed 17805430Rosado 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 publication: PubMed 18316268Kordas 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 publication: PubMed 21439564Roy 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 publication: PubMed 23110976Moodie 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.
- Derived from this study: PubMed 28343659Kordas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca J Stoltzfus, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous fumarate and Zinc oxide in people with Lead Poisoning, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lead concentration (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346188, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.