Effects of Retinoids on CYP2D6 Activity During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2022-10-31

Brief Summary

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Prospective drug interaction study during pregnancy.

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Detailed Description

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

Conditions

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CYP2D6 Polymorphism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, parallel group study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vitamin A

Subjects will receive 3-4weeks of vitamin A

Group Type EXPERIMENTAL

Vitamin A

Intervention Type DRUG

vitamin A daily X3-4 weeks

Control

Subjects will receive no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin A

vitamin A daily X3-4 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes