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NCT03408275 Clinical Trial

Dietry Pattern and Lead Levels in Pregnancy

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03408275
Other study ID # ALSPAC_2
Secondary ID
Status Completed
Phase N/A
First received January 16, 2018
Last updated January 16, 2018
Start date April 1, 1991
Est. completion date December 1, 1992

Study information
Verified date January 2018
Source University of Bristol
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 2167
Est. completion date December 1, 1992
Est. primary completion date December 1, 1992
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: Enrolled in ALSPAC, pregnant -

Exclusion Criteria: Not enrolled in ALSPAC, not pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• None - observational
None - observational

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
University of Bristol Bristol Biomedical Research Unit, Medical Research Council, Wellcome Trust

Outcome
Type Measure Description Time frame Safety issue
Primary Blood lead concentration Blood lead concentration During gestation
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