Dietry Pattern and Lead Levels in Pregnancy

January 16, 2018 updated by: University of Bristol

Dietary Patterns and Variability in Blood Lead Concentrations Among Pregnant British Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Whole blood samples were collected from pregnant women enrolled in the Avon Longitudinal Study of Parents and Children observational birth cohort study and were analysed for lead. Dietary pattern scores were derived from principal components analysis of a food frequency questionnaire. Associations of quartiles of dietary pattern scores, and of food groups categorised by frequency of consumption, with the likelihood of blood lead concentration (B-Pb) ≥5 µg/dl will be identified with adjusted logistic regression (n=2167).

Study Type

Observational

Enrollment (Actual)

2167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria: Enrolled in ALSPAC, pregnant -

Exclusion Criteria: Not enrolled in ALSPAC, not pregnant

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women
Pregnant women enrolled in ALSPAC
Other: None - observational
None - observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lead concentration
Time Frame: During gestation
Blood lead concentration
During gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bristol

Collaborators

Medical Research Council
Wellcome Trust
Bristol Biomedical Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 1991

Primary Completion (Actual)

December 1, 1992

Study Completion (Actual)

December 1, 1992

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALSPAC_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: ALSPAC data available to researchers on application through the website

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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