Mercury LevelsNCT00138333
Mercury Levels in Premature and LBW Infants Receiving Thimerosal-containing Vaccines
An observational study of Mercury Levels, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Argentina.
Trial summary
The goal of the study is to find out how much mercury is in the blood, urine, and stools of premature and low birth weight infants who have received standard childhood vaccines that are given to all infants in Argentina. Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Mercury Levels
- How many people
- 71 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2005to Nov 2006
- 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 32 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: 1) Parent/guardian gives written informed consent. 2) Good health as determined by negative gestational history, subject's medical history and physical assessment. Medical history will include a review of the major body systems (e.g., ear-nose-throat, cardiovascular, respiratory, neurological, gastrointestinal, genitourinary, hematological). 3) Newborn cohort: within 3 days of birth and gestational age = 32 weeks and < 37 weeks and a birth weight = 2000 grams and < 3000 grams. 4) Able to attend the scheduled visits and to comply with the study procedures. Exclusion Criteria: 1) Infant history of vaccinations and date received is unknown or undocumented. 2) Known history of high-level mercury exposure in mother or infant. 3) Any contraindication to routine vaccinations. 4) Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion). 5) Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. 6) HIV-positive mother by history. 7) Personal or immediate family history of congenital immune deficiency. 8) Developmental delay or neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Mercury Levels and Metabolism in Premature and Low Birth Weight (LBW) Infants Receiving Vaccines Containing Thimerosal
The goal of the study is to find out how much mercury is in the blood, urine, and stools of premature and low birth weight infants who have received standard childhood vaccines that are given to all infants in Argentina. Seventy-two newborn premature and low birth weight infants from Durand Acute General hospital will participate in this study. Each infant in the study will need to make two visits, one at the time of vaccination and another 12 hours to 30 days later. Urine, stool, and a small sample of blood will be taken at each visit.
Read the detailed description
The primary objective is to describe the levels of mercury in the blood of premature newborns greater than or equal to 32 weeks and less than 37 weeks gestation and birth weight greater than or equal to 2000 grams but less than 3000 grams, who receive the routine birth dose of Hepatitis B immunization containing ethyl mercury in the form of thimerosal and the birth dose of BCG immunization, and to evaluate the excretion of mercury in these newborns by examining mercury levels in stool and urine. Secondary objectives are: 1) to determine the half-time of mercury in blood following vaccination of premature and low birth weight infants with thimerosal-containing vaccines, and 2) to screen premature and low birth weight infants for evidence of early effects of thimerosal on the kidney by measurement of urinary gamma glutamyl transpeptidase levels. All infants will have stool, urine, and blood samples collected prior to receipt of routine birth hepatitis B and BCG immunization. Cord blood will serve as the baseline blood specimen. Each infant will be seen once at a predetermined follow-up visit time point. There will be 6 follow-up visit time points, with sampling from 12 infants at each time point. All infants will provide blood, urine, and stool specimens at the assigned follow-up visit.
- Conditions
- Mercury Levels
- Keywords
- Thimerosal, mercury levels, low birth weight, Argentina
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startDec 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mercury LevelsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138333
- Sponsor's protocol ID
- 04-046
- Status last verified
- Oct 2007
- First submitted
- 26 Aug 2005
- Last updated
- 11 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mercury Levels and Metabolism in Premature and Low Birth Weight (LBW) Infants Receiving Vaccines Containing Thimerosal
- ClinicalTrials.gov ID
- NCT00138333
- Acronym / sponsor ID
- 04-046
- Conditions
- Mercury Levels
- Keywords
- Thimerosal, mercury levels, low birth weight, Argentina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2005
- Study completion
- Nov 2006
- First posted
- 30 Aug 2005 (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.
The goal of the study is to find out how much mercury is in the blood, urine, and stools of premature and low birth weight infants who have received standard childhood vaccines that are given to all infants in Argentina. Seventy-two newborn premature and low birth weight infants from Durand Acute General hospital will participate in this study. Each infant in the study will need to make two visits, one at the time of vaccination and another 12 hours to 30 days later. Urine, stool, and a small sample of blood will be taken at each visit.
Detailed description
The primary objective is to describe the levels of mercury in the blood of premature newborns greater than or equal to 32 weeks and less than 37 weeks gestation and birth weight greater than or equal to 2000 grams but less than 3000 grams, who receive the routine birth dose of Hepatitis B immunization containing ethyl mercury in the form of thimerosal and the birth dose of BCG immunization, and to evaluate the excretion of mercury in these newborns by examining mercury levels in stool and urine. Secondary objectives are: 1) to determine the half-time of mercury in blood following vaccination of premature and low birth weight infants with thimerosal-containing vaccines, and 2) to screen premature and low birth weight infants for evidence of early effects of thimerosal on the kidney by measurement of urinary gamma glutamyl transpeptidase levels. All infants will have stool, urine, and blood samples collected prior to receipt of routine birth hepatitis B and BCG immunization. Cord blood will serve as the baseline blood specimen. Each infant will be seen once at a predetermined follow-up visit time point. There will be 6 follow-up visit time points, with sampling from 12 infants at each time point. All infants will provide blood, urine, and stool specimens at the assigned follow-up visit.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 32 to 36 weeks
- 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 11 Nov 2011.
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 Levels, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Argentina.
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 11 Nov 2011. 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 Argentina. 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?
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 11 Nov 2011.