Dietary Calcium Supplementation to Reduce Blood Lead in Pregnancy

NCT00558623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2007-11-15

No results posted yet for this study

Summary

Lead accumulates in bone. During pregnancy, physiologic changes occur prompting bone resorption in order to provide calcium to the growing fetal skeleton also release the lead stored in bone into a pregnant woman's circulation. We have previously demonstrated that lead stores mobilized into the circulation of pregnant women pose a major threat to fetal development. This is particularly unfortunate since bone lead stores, once accumulated, persist for decades, thereby jeopardizing the pregnancies of women even if their current lead exposures have subsided. What then can be done for the many thousands of women who have had lead exposure while growing up and who want to have healthy children? To address this question, in 2000, this project embarked on a randomized intervention trial to test whether a bedtime nutritional supplement of 1,000 mg of calcium can significantly reduce fetal lead exposure and toxicity by suppressing bone resorption in the pregnant mother.

Conditions

  • Lead, Blood
  • Pregnancy
  • Bone Resorption

Interventions

DIETARY_SUPPLEMENT

calcium carbonate

daily supplement of 1,200 milligrams calcium (two-600 mg tablets calcium carbonate at bedtime)

Sponsors & Collaborators

  • Mexican National Institute of Public Health

    collaborator OTHER_GOV
  • Brigham and Women's Hospital

    collaborator OTHER
  • University of California Santa Cruz

    collaborator OTHER
  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Howard Hu, MD, ScD · Harvard School of Public Health and University of Michigan

  • Mauricio Hernandez-Avila, MD, ScD · National Institute of Public Health and Ministry of Health, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-01-31
Completion
2005-04-30

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00558623 on ClinicalTrials.gov