Dietary HabitsNCT03408275
Dietry Pattern and Lead Levels in Pregnancy
An observational study of Dietary Habits and Lead Poisoning, run by University of Bristol.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Lead Poisoning, Pregnancy Related
- What is being tested?
- None - observational
- How many people
- 2,167 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 1991to 1 Dec 1992
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: 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.
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).
- Conditions
- Dietary Habits, Lead Poisoning, Pregnancy Related
- Being tested
- None - observational
- Keywords
- Dietary patterns, Pregnancy, Woman, Diet, Lead, ALSPAC
- Medical subject headings
- Feeding Behavior, Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - observationalOther
None - observational
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women enrolled in ALSPAC Receives: Other: None - observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lead concentration
Blood lead concentration
Measured: During gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Apr 1991
- Primary completion1 Dec 1992
- Study completion1 Dec 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Medical Research Council, Bristol Biomedical Research Unit
- Responsible party
- Sponsor
- Investigators
- Nic Timpson, PhD, Study director, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408275
- Sponsor's protocol ID
- ALSPAC_2
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Patterns and Variability in Blood Lead Concentrations Among Pregnant British Women
- ClinicalTrials.gov ID
- NCT03408275
- Acronym / sponsor ID
- ALSPAC_2
- Conditions
- Dietary Habits, Lead Poisoning, Pregnancy Related
- Keywords
- Dietary patterns, Pregnancy, Woman, Diet, Lead, ALSPAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,167 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Collaborators
- Wellcome Trust, Medical Research Council, Bristol Biomedical Research Unit
- Study start
- 1 Apr 1991 (actual)
- Primary completion
- 1 Dec 1992 (actual)
- Study completion
- 1 Dec 1992 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: None - observationalPregnant women enrolled in ALSPAC |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - observationalNone - observational | Other | Pregnant women |
Primary outcome
Blood lead concentration
Time frame: During gestation
Blood lead concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nic Timpson, PhD study director
University of Bristol
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits and Lead Poisoning, run by University of Bristol.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lead concentration (time frame: During gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.