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Lead Mobilization & Bone Turnover in Pregnancy/Lactation

NCT ID: NCT00011726

Last Updated: 2006-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-08-31

Study Completion Date

2002-12-31

Brief Summary

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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

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Conditions

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Lead Poisoning

Keywords

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Pregnancy Lead Exposure Lactation Bone Mineralization Maternal-Fetal Exchange

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role lead

References

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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. doi: 10.1359/jbmr.1998.13.11.1768.

Reference Type BACKGROUND
PMID: 9797487 (View on PubMed)

Sowers MF, Scholl T, Harris L, Jannausch M. Bone loss in adolescent and adult pregnant women. Obstet Gynecol. 2000 Aug;96(2):189-93. doi: 10.1016/s0029-7844(00)00903-0.

Reference Type BACKGROUND
PMID: 10908761 (View on PubMed)

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. doi: 10.1016/s0029-7844(98)00157-4.

Reference Type BACKGROUND
PMID: 9699743 (View on PubMed)

Goodlin RC. High third-trimester ferritin concentration: associations with very preterm delivery, infection, and maternal nutritional status. Obstet Gynecol. 1999 Jan;93(1):156. doi: 10.1016/s0029-7844(98)00427-x. No abstract available.

Reference Type BACKGROUND
PMID: 9916975 (View on PubMed)

Scholl TO. Teenage pregnancy. In "Cambridge Encyclopedia of Growth and Development", SJ Ulijaszek, FE Johnson, MA Preece (eds), Cambridge Univ Press, 312-13,1998

Reference Type BACKGROUND

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)

Reference Type BACKGROUND

Other Identifiers

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7437-CP-001

Identifier Type: -

Identifier Source: org_study_id