Lead Mobilization & Bone Turnover in Pregnancy/Lactation

This study has been completed.

Sponsor:

Information provided by:

National Institute of Environmental Health Sciences (NIEHS)

ClinicalTrials.gov Identifier:

NCT00011726

First received: February 27, 2001

Last updated: March 22, 2006

Last verified: March 2006

History of Changes

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:	Additional Descriptors: Convenience Sample Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding Lead Poisoning Poisoning

U.S. FDA Resources

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

Ages Eligible for Study:	12 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

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.

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
Study First Received:	February 27, 2001
Last Updated:	March 22, 2006
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):

Pregnancy
Lead Exposure
Lactation
Bone Mineralization
Maternal-Fetal Exchange

Additional relevant MeSH terms:

Lead Poisoning
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 22, 2013

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