ClinicalTrials.gg
CompletedNCT00011726Updated Mar 23, 2006

Lead Mobilization & Bone Turnover in Pregnancy/Lactation

An observational study in Lead Poisoning, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed. Open to female participants aged 12 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-03-23.

Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational

Study type
Observational
Model
Natural history
Time perspective
Prospective
Enrollment
1,000
Ages
12 Years to 35 Years
Sex
Female
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Study 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.

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Conditions studied

  • Lead Poisoning

Keywords

  • Pregnancy
  • Lead Exposure
  • Lactation
  • Bone Mineralization
  • Maternal-Fetal Exchange
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In context

Lead Poisoning

27 studies on the registry are indexed under Lead Poisoning; 2 are open to participants now.

This study's enrollment of 1,000 is above the median of 350 across 14 observational studies indexed under Lead Poisoning.

Browse Lead Poisoning studies →

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 183 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

  1. Positive pregnancy test, age 12-35 and ;
  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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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Study design

Observational model
Natural history
Time perspective
Prospective
Enrollment
1,000 participants
06

Study locations

No study locations are listed for this record.

07

References and documents

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. doi: 10.1359/jbmr.1998.13.11.1768. PubMed 9797487 ↗
  • 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. PubMed 10908761 ↗
  • 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. PubMed 9699743 ↗
  • 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. PubMed 9916975 ↗
  • 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)
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00011726
First posted
Mar 1, 2001
Start date
Aug 1996
Completion
Dec 2002
Last update
Mar 23, 2006
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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