Effects of Retinoids on CYP2D6 Activity During Pregnancy

Phase 1

Completed

• Conditions: CYP2D6 Polymorphism
• Interventions: Drug: Vitamin A

• Registration Number: NCT03117660
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Study Start: 2017-07-25
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A	Vitamin A	Subjects will receive 3-4weeks of vitamin A

Primary Outcome Measures

Name	Time	Method
CYP2D6 activity: dextromethorphan metabolic ratio	4 weeks	dextromethorphan metabolic ratio change from baseline during pregnancy

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States