- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00011726
Lead Mobilization & Bone Turnover in Pregnancy/Lactation
March 22, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
We are examining the role of maternal bone lead turnover during pregnancy and lactation as a potential source of lead exposure for the fetus and the infant (via breast milk).
A cohort, ascertained at entry to care, consists of >1000 women to be followed through pregnancy.
In the postpartum subjects are recruited for a nested case control study to assess the influence of lactation on maternal bone density, maternal blood lead and breast milk lead.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment
1000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
- Positive pregnancy test, age 12-35 and informed consent;
- Gestation <28 weeks at entry to prenatal care;
- No history of serious chronic or metabolic diseases, which could affect maternal growth or bone density;
- Not corticosteroid user or diagnosed use of illicit drugs;
- Eligible for lactation study: Ascertainment during or participation in the pregnancy study and a negative pregnancy test.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Natural History
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sowers M, Jannausch M, Scholl T, Schall J. The reproducibility of ultrasound bone measures in a triethnic population of pregnant adolescents and adult women. J Bone Miner Res. 1998 Nov;13(11):1768-74. doi: 10.1359/jbmr.1998.13.11.1768.
- Sowers MF, Scholl T, Harris L, Jannausch M. Bone loss in adolescent and adult pregnant women. Obstet Gynecol. 2000 Aug;96(2):189-93. doi: 10.1016/s0029-7844(00)00903-0.
- Scholl TO. High third-trimester ferritin concentration: associations with very preterm delivery, infection, and maternal nutritional status. Obstet Gynecol. 1998 Aug;92(2):161-6. doi: 10.1016/s0029-7844(98)00157-4.
- Goodlin RC. High third-trimester ferritin concentration: associations with very preterm delivery, infection, and maternal nutritional status. Obstet Gynecol. 1999 Jan;93(1):156.
- Scholl TO. Teenage pregnancy. In "Cambridge Encyclopedia of Growth and Development", SJ Ulijaszek, FE Johnson, MA Preece (eds), Cambridge Univ Press, 312-13,1998
- Scholl TO, Reilly T. Essential trace elements and mineral nutrition in human pregnancy. In "Clinical nutrition of the essential trace elements and mineral - The Guide for Health Professionals", John R. Bogden, Leslie Klevay (eds), Humana Press, 1999. ( In press)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1996
Study Completion
December 1, 2002
Study Registration Dates
First Submitted
February 27, 2001
First Submitted That Met QC Criteria
February 28, 2001
First Posted (Estimate)
March 1, 2001
Study Record Updates
Last Update Posted (Estimate)
March 23, 2006
Last Update Submitted That Met QC Criteria
March 22, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7437-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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