- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03408275
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
|
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
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
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
-
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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