CYP2D6 Polymorphism
Conditions
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.
Interventions
DRUGVitamin A
vitamin A daily X3-4 weeks
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Prospective, randomized, parallel group study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CYP2D6 activity: dextromethorphan metabolic ratio | 4 weeks | dextromethorphan metabolic ratio change from baseline during pregnancy |
Countries
United States
Outcome results
None listed