NCT00011726

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1996

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2001

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

March 23, 2006

Status Verified

March 1, 2006

First QC Date

February 27, 2001

Last Update Submit

March 22, 2006

Conditions

Keywords

PregnancyLead ExposureLactationBone MineralizationMaternal-Fetal Exchange

Eligibility Criteria

Age12 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 9797487BACKGROUND
  • 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.

    PMID: 10908761BACKGROUND
  • 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.

    PMID: 9699743BACKGROUND
  • 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.

    PMID: 9916975BACKGROUND
  • Scholl TO. Teenage pregnancy. In "Cambridge Encyclopedia of Growth and Development", SJ Ulijaszek, FE Johnson, MA Preece (eds), Cambridge Univ Press, 312-13,1998

    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)

    BACKGROUND

MeSH Terms

Conditions

Lead PoisoningBreast Feeding

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced DisordersFeeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

February 27, 2001

First Posted

March 1, 2001

Study Start

August 1, 1996

Study Completion

December 1, 2002

Last Updated

March 23, 2006

Record last verified: 2006-03