NCT00558623

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
670

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
Last Updated

November 15, 2007

Status Verified

November 1, 2007

First QC Date

November 14, 2007

Last Update Submit

November 14, 2007

Conditions

Lead, BloodPregnancyBone Resorption

Keywords

lead, bloodpregnancycalciumrandomized trialdietary supplementationbone resorption

Outcome Measures

Primary Outcomes (1)

  • Blood Lead Concentration, Plasma Lead Concentration

    2nd, 3rd trimester pregnancy and 1,4,7,12 months postpartum

Secondary Outcomes (1)

  • Urinary Cross-linked N-telopeptides (marker of bone resorption)

    2nd, 3rd trimester of pregnancy and 1,4,7,12 months postpartum

Study Arms (1)

1

PLACEBO COMPARATOR

Placebo

Dietary Supplement: calcium carbonate

Interventions

calcium carbonateDIETARY_SUPPLEMENT

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

Also known as: Lederle, Inc.
1

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • being in the first trimester of pregnancy (no more than 14 weeks gestation); not presenting with a high-risk pregnancy; residing and plans to reside in the metropolitan Mexico City area for approximately 5 years; agreeing to participate and signing the informed consent form.

You may not qualify if:

  • high-risk pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mauricio Hernandez-Avila

Cuernavaca, Morelos, 62100, Mexico

Location

Related Publications (2)

  • Perng W, Tamayo-Ortiz M, Tang L, Sanchez BN, Cantoral A, Meeker JD, Dolinoy DC, Roberts EF, Martinez-Mier EA, Lamadrid-Figueroa H, Song PXK, Ettinger AS, Wright R, Arora M, Schnaas L, Watkins DJ, Goodrich JM, Garcia RC, Solano-Gonzalez M, Bautista-Arredondo LF, Mercado-Garcia A, Hu H, Hernandez-Avila M, Tellez-Rojo MM, Peterson KE. Early Life Exposure in Mexico to ENvironmental Toxicants (ELEMENT) Project. BMJ Open. 2019 Aug 26;9(8):e030427. doi: 10.1136/bmjopen-2019-030427.

    PMID: 31455712DERIVED

  • Ettinger AS, Lamadrid-Figueroa H, Mercado-Garcia A, Kordas K, Wood RJ, Peterson KE, Hu H, Hernandez-Avila M, Tellez-Rojo MM. Effect of calcium supplementation on bone resorption in pregnancy and the early postpartum: a randomized controlled trial in Mexican women. Nutr J. 2014 Dec 16;13(1):116. doi: 10.1186/1475-2891-13-116.

    PMID: 25511814DERIVED

MeSH Terms

Conditions

Bone Resorption

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 15, 2007

Study Start

January 1, 2001

Study Completion

April 1, 2005

Last Updated

November 15, 2007

Record last verified: 2007-11

Locations

ME(1)