Mercury PoisoningNCT00013858
Environmental Contaminants and Infant Development
An observational study of Mercury Poisoning and Lead Poisoning, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in Canada.
Trial summary
This study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of Inuit infants-one in Northern Quebec; the other in Greenland. Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Mercury Poisoning, Lead Poisoning
- How many people
- 280 participants
- Where
- 1 siteCanada
- Study dates
- Jan 1997to Aug 2011
- Phase
- Observational
- 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 1 to 1 day
- All sexes
- Healthy volunteers accepted
- Child
infant born during recruitment period to a mother who is a resident of Povungnituk, Inukjuak, and Kuujjuarapik, Quebec or Nuuk, Greenland
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of Inuit infants-one in Northern Quebec; the other in Greenland.
Read the detailed description
Due to prevailing weather patterns and ocean currents, certain environmental contaminants are transported to the Arctic region. The Inuit are among the most heavily exposed populations on earth due to the prevalence of these contaminants in traditional foods that comprise a large portion of their diet. The contaminants assessed in this study include polychlorinated biphenyls (PCBs), methylmercury, selenium, organochlorine pesticides, and lead. These contaminants are measured in umbilical cord blood samples obtained at birth, milk samples obtained from breast-feeding mothers and, in the case of mercury, hair samples obtained from the mothers. Omega-3 and omega-6 fatty acids are also assessed in these samples to examine the degree to which these nutrients may protect against adverse effects attributable to these contaminants.
- Conditions
- Mercury Poisoning, Lead Poisoning
- Keywords
- methylmercury, PCBs, lead, fish consumption, breast-feeding
- Medical subject headings
- Mercury Poisoning, Lead Poisoning, Breast Feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2001 (estimated)
- Study startJan 1997
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mercury PoisoningStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Indian and Northern Affairs, Canada, Health Canada, Danish Institute for Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013858
- Sponsor's protocol ID
- 7902-CP-001
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2001
- Last updated
- 14 Apr 2015
- Results posted
- No
Publications
Dewailly, E., Bruneau, S., Ayotte, P., Liliberte, C., Gingras, S. Belander, D. and Ferron, L. Health status at birth of Inuit newborn prenatally exposed to organochlorines - Chemosphre, 1993, 27: 359-366.
Dewailly E, Ayotte P, Bruneau S, Laliberte C, Muir DC, Norstrom RJ. Inuit exposure to organochlorines through the aquatic food chain in arctic quebec. Environ Health Perspect. 1993 Dec;101(7):618-20. doi: 10.1289/ehp.93101618.
PubMed 8143594Jacobson SW, Fein GG, Jacobson JL, Schwartz PM, Dowler JK. The effect of intrauterine PCB exposure on visual recognition memory. Child Dev. 1985 Aug;56(4):853-60.
PubMed 3930167Jacobson JL, Jacobson SW. Intellectual impairment in children exposed to polychlorinated biphenyls in utero. N Engl J Med. 1996 Sep 12;335(11):783-9. doi: 10.1056/NEJM199609123351104.
PubMed 8703183
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Contaminants and Infant Development
- ClinicalTrials.gov ID
- NCT00013858
- Acronym / sponsor ID
- 7902-CP-001
- Conditions
- Mercury Poisoning, Lead Poisoning
- Keywords
- methylmercury, PCBs, lead, fish consumption, breast-feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Collaborators
- Indian and Northern Affairs, Canada, Health Canada, Danish Institute for Public Health
- Study start
- Jan 1997
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Apr 2001 (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.
This study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of Inuit infants-one in Northern Quebec; the other in Greenland.
Detailed description
Due to prevailing weather patterns and ocean currents, certain environmental contaminants are transported to the Arctic region. The Inuit are among the most heavily exposed populations on earth due to the prevalence of these contaminants in traditional foods that comprise a large portion of their diet. The contaminants assessed in this study include polychlorinated biphenyls (PCBs), methylmercury, selenium, organochlorine pesticides, and lead. These contaminants are measured in umbilical cord blood samples obtained at birth, milk samples obtained from breast-feeding mothers and, in the case of mercury, hair samples obtained from the mothers. Omega-3 and omega-6 fatty acids are also assessed in these samples to examine the degree to which these nutrients may protect against adverse effects attributable to these contaminants.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Apr 2015.
- BackgroundDewailly, E., Bruneau, S., Ayotte, P., Liliberte, C., Gingras, S. Belander, D. and Ferron, L. Health status at birth of Inuit newborn prenatally exposed to organochlorines - Chemosphre, 1993, 27: 359-366.
- Background: PubMed 8143594Dewailly E, Ayotte P, Bruneau S, Laliberte C, Muir DC, Norstrom RJ. Inuit exposure to organochlorines through the aquatic food chain in arctic quebec. Environ Health Perspect. 1993 Dec;101(7):618-20. doi: 10.1289/ehp.93101618.
- Background: PubMed 3930167Jacobson SW, Fein GG, Jacobson JL, Schwartz PM, Dowler JK. The effect of intrauterine PCB exposure on visual recognition memory. Child Dev. 1985 Aug;56(4):853-60.
- Background: PubMed 8703183Jacobson JL, Jacobson SW. Intellectual impairment in children exposed to polychlorinated biphenyls in utero. N Engl J Med. 1996 Sep 12;335(11):783-9. doi: 10.1056/NEJM199609123351104.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mercury Poisoning and Lead Poisoning, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Apr 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 Canada. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013858, which also lists 4 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 14 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.