Lead Mobilization & Bone Turnover in Pregnancy/Lactation

Lead Poisoning Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011726
• Other study ID #: 7437-CP-001
• Status: Completed
• Phase: N/A
• First received: February 27, 2001
• Last updated: March 22, 2006
• Start date: August 1996
• Est. completion date: December 2002

Study information

• Verified date: March 2006
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 35 Years

Eligibility

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.

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Lead Poisoning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

References & Publications (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. — View Citation

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)

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. — View Citation

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

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. — View Citation

Sowers MF, Scholl T, Harris L, Jannausch M. Bone loss in adolescent and adult pregnant women. Obstet Gynecol. 2000 Aug;96(2):189-93. — View Citation