CClinicalTrials.gg
CompletedNCT03408275Updated Jan 23, 2018

Dietry Pattern and Lead Levels in Pregnancy

An observational study in Dietary Habits, Lead Poisoning and Pregnancy Related, sponsored by University of Bristol. Completed. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by University of Bristol · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,167
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Dietary Habits
  • Lead Poisoning
  • Pregnancy Related

Keywords

  • Dietary patterns
  • Pregnancy
  • Woman
  • Diet
  • Lead
  • ALSPAC
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Eligibility criteria

Inclusion Criteria: Enrolled in ALSPAC, pregnant -

Exclusion Criteria: Not enrolled in ALSPAC, not pregnant

-

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,167 participants (actual)
Patient registry
No

Groups and cohorts

  • Pregnant women

    Pregnant women enrolled in ALSPAC

    Other: None - observational

Interventions

  • OtherNone - observational

    None - observational

05

What researchers measure

Primary outcomes

  1. Blood lead concentration

    Blood lead concentration

    Time frame: During gestation

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03408275
Lead sponsor
University of Bristol
Collaborators
Wellcome Trust, Medical Research Council, Bristol Biomedical Research Unit
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Apr 1, 1991
Primary completion
Dec 1, 1992
Completion
Dec 1, 1992
Last update
Jan 23, 2018

Study contacts

Nic Timpson, PhD
study director · University of Bristol

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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