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OpenTrials
Completed

NCT Number: NCT03117660

Effects of Retinoids on CYP2D6 Activity During Pregnancy

Prospective drug interaction study during pregnancy.

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Key information

Conditions

CYP2D6 Polymorphism

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin A

Drug

vitamin A daily X3-4 weeks

Primary outcomes

  1. CYP2D6 activity: dextromethorphan metabolic ratio

    Time frame: 4 weeks

    dextromethorphan metabolic ratio change from baseline during pregnancy

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2017
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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