Dietary Calcium Supplementation to Reduce Blood Lead in Pregnancy
NCT00558623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 670
Last updated 2007-11-15
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
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