Effects of Retinoids on CYP2D6 Activity During Pregnancy

University of Washington

Status and phase: Completed; Phase 1

Conditions: CYP2D6 Polymorphism

Treatments: Drug: Vitamin A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03117660

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

STUDY00001620

Details and patient eligibility

About

Prospective drug interaction study during pregnancy.

Full description

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

Enrollment: 82 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Vitamin A

Experimental group

Description:

Subjects will receive 3-4weeks of vitamin A

Treatment:

Drug: Vitamin A

Control

No Intervention group

Description:

Subjects will receive no treatment