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Lead Mobilization & Bone Turnover in Pregnancy/Lactation

This study has been completed.

Sponsored by: National Institute of Environmental Health Sciences (NIEHS)
Information provided by: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00011726
  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

MedlinePlus related topics:   Breast Feeding    Lead Poisoning    Poisoning   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Convenience Sample, Prospective Study

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
  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:

Study ID Numbers:   7437-CP-001
First Received:   February 27, 2001
Last Updated:   March 22, 2006
ClinicalTrials.gov Identifier:   NCT00011726
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  

Study placed in the following topic categories:
Lead Poisoning
Poisoning
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on October 15, 2008




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