CYP2D6 PolymorphismPhase 1NCT03117660
Effects of Retinoids on CYP2D6 Activity During Pregnancy
A Phase 1 study testing Vitamin A in people with CYP2D6 Polymorphism, run by University of Washington at 1 site in United States.
Trial summary
Prospective drug interaction study during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- CYP2D6 Polymorphism
- What is being tested?
- Vitamin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 31 Oct 2022
- Phase
- Phase 1
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancies
- Extensive metabolizers
Who cannot join
- Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease
- Productive cough
- Fever
- Known kidney disease
- Known liver disease
- Diabetes
Show all 16Show fewer
- Obesity
- Bipolar disease
- Attention deficit disorder
- Social phobia
- Allergy or history of adverse event with dextromethorphan
- Drugs, foods, beverages or dietary supplements that interact with CYP2D6 or dextromethorphan
- dextromethorphan
- Unable to give written informed consent
- Inability to fast
- Concurrent use of vitamin A supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations
Prospective drug interaction study during pregnancy.
Read the detailed description
A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A administration during pregnancy and compared to postpartum control.
- Conditions
- CYP2D6 Polymorphism
- Being tested
- Vitamin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
vitamin A daily X3-4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Experimental | Subjects will receive 3-4weeks of vitamin A Receives: Drug: Vitamin A |
| Control | No intervention | Subjects will receive no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP2D6 activity: dextromethorphan metabolic ratio
dextromethorphan metabolic ratio change from baseline during pregnancy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start25 Jul 2017
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CYP2D6 PolymorphismStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, parallel group study
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Mary Hebert, University of Washington
- Investigators
- Mary F Hebert, PharmD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117660
- Sponsor's protocol ID
- STUDY00001620
- Other IDs
- R01GM124264-01
- Status last verified
- Nov 2022
- First submitted
- 10 Apr 2017
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will adhere to the NIH Grant Policy on Sharing Research Data. That is, after final data collection and analysis and after full peer review is performed on the data, the de-identified data generated by this project will be made available when requested by the academic community and researchers-at-large contingent upon Material Transfer Agreements with the University of Washington.
Publications
Somani ST, Zeigler M, Fay EE, Leahy M, Bermudez B, Totah RA, Hebert MF. Changes in erythrocyte membrane epoxyeicosatrienoic, dihydroxyeicosatrienoic, and hydroxyeicosatetraenoic acids during pregnancy. Life Sci. 2021 Jan 1;264:118590. doi: 10.1016/j.lfs.2020.118590. Epub 2020 Oct 15.
PubMed 33069736Amaeze OU, Czuba LC, Yadav AS, Fay EE, LaFrance J, Shum S, Moreni SL, Mao J, Huang W, Isoherranen N, Hebert MF. Impact of Pregnancy and Vitamin A Supplementation on CYP2D6 Activity. J Clin Pharmacol. 2023 Mar;63(3):363-372. doi: 10.1002/jcph.2169. Epub 2022 Nov 15.
PubMed 36309846Czuba LC, Fay EE, LaFrance J, Smith CK, Shum S, Moreni SL, Mao J, Isoherranen N, Hebert MF. Plasma Retinoid Concentrations Are Altered in Pregnant Women. Nutrients. 2022 Mar 25;14(7):1365. doi: 10.3390/nu14071365.
PubMed 35405978
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations
- ClinicalTrials.gov ID
- NCT03117660
- Acronym / sponsor ID
- STUDY00001620
- Conditions
- CYP2D6 Polymorphism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 18 Apr 2017 (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.
Prospective drug interaction study during pregnancy.
Detailed description
A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A administration during pregnancy and compared to postpartum control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, parallel group study
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Experimental | Drug: Vitamin ASubjects will receive 3-4weeks of vitamin A |
| Control | No intervention | –Subjects will receive no treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton pregnancies
- Extensive metabolizers
Key exclusion criteria (16 listed)
- Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease
- Productive cough
- Fever
- Known kidney disease
- Known liver disease
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 |
|---|---|---|
| Vitamin Avitamin A daily X3-4 weeks | Drug | Vitamin A |
Primary outcome
CYP2D6 activity: dextromethorphan metabolic ratio
Time frame: 4 weeks
dextromethorphan metabolic ratio change from baseline during pregnancy
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 4 Nov 2022.
- Background: PubMed 33069736Somani ST, Zeigler M, Fay EE, Leahy M, Bermudez B, Totah RA, Hebert MF. Changes in erythrocyte membrane epoxyeicosatrienoic, dihydroxyeicosatrienoic, and hydroxyeicosatetraenoic acids during pregnancy. Life Sci. 2021 Jan 1;264:118590. doi: 10.1016/j.lfs.2020.118590. Epub 2020 Oct 15.
- Background: PubMed 36309846Amaeze OU, Czuba LC, Yadav AS, Fay EE, LaFrance J, Shum S, Moreni SL, Mao J, Huang W, Isoherranen N, Hebert MF. Impact of Pregnancy and Vitamin A Supplementation on CYP2D6 Activity. J Clin Pharmacol. 2023 Mar;63(3):363-372. doi: 10.1002/jcph.2169. Epub 2022 Nov 15.
- Background: PubMed 35405978Czuba LC, Fay EE, LaFrance J, Smith CK, Shum S, Moreni SL, Mao J, Isoherranen N, Hebert MF. Plasma Retinoid Concentrations Are Altered in Pregnant Women. Nutrients. 2022 Mar 25;14(7):1365. doi: 10.3390/nu14071365.
- Individual participant dataSharing planned: Yes. The investigators will adhere to the NIH Grant Policy on Sharing Research Data. That is, after final data collection and analysis and after full peer review is performed on the data, the de-identified data generated by this project will be made available when requested by the academic community and researchers-at-large contingent upon Material Transfer Agreements with the University of Washington.
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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.
Mary F Hebert, PharmD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin A in people with CYP2D6 Polymorphism, run by University of Washington at 1 site in United States.
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 2 inclusion and 16 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
CYP2D6 activity: dextromethorphan metabolic ratio (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117660, which also lists 3 linked publications.
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 4 Nov 2022.