Lead Mobilization & Bone Turnover in Pregnancy/Lactation - Tabular View

Tracking Information
First Received Date ^ICMJE	February 27, 2001
Last Updated Date	March 22, 2006
Start Date ^ICMJE	August 1996
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00011726 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Lead Mobilization & Bone Turnover in Pregnancy/Lactation
Official Title ^ICMJE
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Natural History, Longitudinal, Convenience Sample, Prospective Study
Condition ^ICMJE	Lead Poisoning
Intervention ^ICMJE
Study Arms / Comparison Groups
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. Sowers MF, Scholl T, Harris L, Jannausch M. Bone loss in adolescent and adult pregnant women. Obstet Gynecol. 2000 Aug;96(2):189-93. 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. Goodlin RC. High third-trimester ferritin concentration: associations with very preterm delivery, infection, and maternal nutritional status. Obstet Gynecol. 1999 Jan;93(1):156. No abstract available.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1000
Completion Date	December 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	12 Years to 35 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00011726
Responsible Party
Study ID Numbers ^ICMJE	7437-CP-001
Study Sponsor ^ICMJE	National Institute of Environmental Health Sciences (NIEHS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Environmental Health Sciences (NIEHS)
Verification Date	March 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP