Dietary Calcium Supplementation to Reduce Blood Lead in Pregnancy
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|ClinicalTrials.gov Identifier: NCT00558623|
Recruitment Status : Completed
First Posted : November 15, 2007
Last Update Posted : November 15, 2007
|Condition or disease||Intervention/treatment||Phase|
|Lead, Blood Pregnancy Bone Resorption||Dietary Supplement: calcium carbonate||Not Applicable|
Recent evidence indicates that there is a marked increase in the mobilization of lead from maternal bone stores into circulation during pregnancy and lactation. Furthermore, data from our group and others indicate that this phenomenon carries a significant risk of fetal toxicity in the form of growth (decreased birth weight, head circumference, birth length) and subsequent cognitive development. These findings pose a major public health problem, even among societies with declining lead exposure, given the persistence of pockets of high lead exposure (including some communities living in proximity to hazardous waste) as well as the long residence time of lead in bone (years to decades). One possible strategy for suppressing the mobilization of maternal bone lead stores during pregnancy is nutritional intervention. We are conducting a randomized, double-blinded, placebo-controlled trial of dietary supplements containing 1,200 milligrams of calcium as a means of suppressing bone resorption and the resulting mobilization of lead from bone into plasma during pregnancy, and into breast milk during the postpartum period. We are taking maternal measurements of pre-pregnancy and postpartum bone lead using our K-x-ray fluorescence technology; bone resorption (by assaying N-telopeptide of type I collagen in urine [urinary NTX]), whole blood lead, and plasma lead (using special collection techniques and measured by IDTIMS) during pre-pregnancy, the first, second, third trimesters and at one and four months postpartum; and breast milk lead levels at one and four months postpartum.
We are measuring maternal plasma and breast milk lead levels as these are the most direct sources of fetal and infant lead exposures, and recent research suggests that maternal venous blood lead levels do not adequately reflect either of these parameters. We are testing the hypothesis that supplements will significantly decrease urinary NTX, plasma lead, and breast milk lead levels. We are also exploring the relationship of plasma lead levels to birth anthropometry measures. This research, if successful, may provide a means of preventing secondary toxicity from accumulated lead burdens among women of reproductive age.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||670 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Controlled Trial in Pregnancy of Dietary Supplements for Suppression of Bone Resorption and Mobilization of Lead Into Plasma|
|Study Start Date :||January 2001|
|Actual Study Completion Date :||April 2005|
Placebo Comparator: 1
Dietary Supplement: calcium carbonate
daily supplement of 1,200 milligrams calcium (two-600 mg tablets calcium carbonate at bedtime)
Other Name: Lederle, Inc.
- Blood Lead Concentration, Plasma Lead Concentration [ Time Frame: 2nd, 3rd trimester pregnancy and 1,4,7,12 months postpartum ]
- Urinary Cross-linked N-telopeptides (marker of bone resorption) [ Time Frame: 2nd, 3rd trimester of pregnancy and 1,4,7,12 months postpartum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558623
|Cuernavaca, Morelos, Mexico, 62100|
|Principal Investigator:||Howard Hu, MD, ScD||Harvard School of Public Health and University of Michigan|
|Principal Investigator:||Mauricio Hernandez-Avila, MD, ScD||National Institute of Public Health and Ministry of Health, Mexico|