NCT03408275

Brief Summary

During pregnancy lead crosses the placenta freely and can have adverse effects on the fetus, with the potential for life-long impact on the child. Identification of dietary patterns and food groups in pregnancy in relation to measures of lead status could provide a more useful alternative to a nutrient-specific advice to minimise fetal exposure to lead during pregnancy. The aim is to evaluate whether dietary patterns and food groups are associated with blood lead concentrations in pregnancy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,167

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1991

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1991

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1992

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1992

Completed
25.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

January 16, 2018

Last Update Submit

January 16, 2018

Conditions

Keywords

Dietary patternsPregnancyWomanDietLeadALSPAC

Outcome Measures

Primary Outcomes (1)

  • Blood lead concentration

    Blood lead concentration

    During gestation

Study Arms (1)

Pregnant women

Pregnant women enrolled in ALSPAC

Other: None - observational

Interventions

None - observational

Pregnant women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample for this analysis was derived from the Avon Longitudinal Study of Parents and Children (ALSPAC), which is a UK-based birth cohort set up to investigate environmental and genetic influences on health and disease. ALSPAC recruited 14,541 pregnant women resident in Avon, UK with expected dates of delivery between 1st April 1991 and 31st December 1992.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding BehaviorLead Poisoning

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorHeavy Metal PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Nic Timpson, PhD

    University of Bristol

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 23, 2018

Study Start

April 1, 1991

Primary Completion

December 1, 1992

Study Completion

December 1, 1992

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access