Effects of Retinoids on CYP2D6 Activity During Pregnancy

November 1, 2022 updated by: Mary Hebert, University of Washington

Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations

Prospective drug interaction study during pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A administration during pregnancy and compared to postpartum control.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin A
Subjects will receive 3-4weeks of vitamin A
Drug: Vitamin A
vitamin A daily X3-4 weeks
No Intervention: Control
Subjects will receive no treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Mary F Hebert, PharmD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 25, 2017

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001620
  • R01GM124264-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on CYP2D6 Polymorphism

Clinical Trials on Vitamin A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe