ClinicalTrials.gov
ClinicalTrials.gov Menu

Lead Mobilization & Bone Turnover in Pregnancy/Lactation

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.
ClinicalTrials.gov Identifier: NCT00011726
Recruitment Status : Completed
First Posted : March 1, 2001
Last Update Posted : March 23, 2006
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)

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.

Condition or disease
Lead Poisoning

Study Type : Observational
Enrollment : 1000 participants
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : August 1996
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

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 Posted: March 1, 2001    Key Record Dates
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