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Lead Mobilization & Bone Turnover in Pregnancy/Lactation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011726
First Posted: March 1, 2001
Last Update Posted: March 23, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
  Purpose
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.

Condition
Lead Poisoning

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 1000
Study Start Date: August 1996
Estimated Study Completion Date: December 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  1. Positive pregnancy test, age 12-35 and informed consent;
  2. Gestation <28 weeks at entry to prenatal care;
  3. No history of serious chronic or metabolic diseases, which could affect maternal growth or bone density;
  4. Not corticosteroid user or diagnosed use of illicit drugs;
  5. Eligible for lactation study: Ascertainment during or participation in the pregnancy study and a negative pregnancy test.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Scholl TO. High third-trimester ferritin concentrations. A reply to Robert C. Goodlin. Obstet Gynecol 93:156,1999
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)

ClinicalTrials.gov Identifier: NCT00011726     History of Changes
Other Study ID Numbers: 7437-CP-001
First Submitted: February 27, 2001
First Posted: March 1, 2001
Last Update Posted: March 23, 2006
Last Verified: March 2006

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Pregnancy
Lead Exposure
Lactation
Bone Mineralization
Maternal-Fetal Exchange

Additional relevant MeSH terms:
Poisoning
Lead Poisoning
Chemically-Induced Disorders