Effects of Retinoids on CYP2D6 Activity During Pregnancy | NCT03117660

Studies
Effects of Retinoids on CYP2D6 Activity During Pregnancy

NCT03117660

Sponsor

University of Washington

Status

Completed

Last Update Posted

Nov 4, 2022Actual

Enrollment

82Actual

Phase

Phase 1

Conditions

CYP2D6 Polymorphism

Interventions

Vitamin A

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01GM124264-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2017Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Oct 31, 2022Actual

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Apr 12, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2022

Last Update Posted Date

Nov 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mary Hebert, Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Name	Class
National Institute of General Medical Sciences (NIGMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin A	Experimental	Subjects will receive 3-4weeks of vitamin A	Drug: Vitamin A
Control	No Intervention	Subjects will receive no treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin A	Drug	vitamin A daily X3-4 weeks	Vitamin A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CYP2D6 activity: dextromethorphan metabolic ratio	dextromethorphan metabolic ratio change from baseline during pregnancy	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancies
Extensive metabolizers

Exclusion Criteria:

Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease
Productive cough
Fever
Known kidney disease
Known liver disease
Diabetes
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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnancy study

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary F Hebert, PharmD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington		Seattle	Washington	98195	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33069736	Background	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.
36309846	Background	Amaeze 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.

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839