Effects of Retinoids on CYP2D6 Activity During Pregnancy

CYP2D6 Polymorphism Clinical Trial

Official title:

Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117660
• Other study ID #: STUDY00001620
• Secondary ID: R01GM124264-01
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2017
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective drug interaction study during pregnancy.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• CYP2D6 Polymorphism

Intervention

Drug:
• Vitamin A
vitamin A daily X3-4 weeks

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Amaeze OU, Czuba LC, Yadav AS, Fay EE, LaFrance J, Shum S, Moreni SL, Mao J, Huang W, Isoherranen N, Hebert MF. Impact of Pregnancy and Vitamin A Supplementation on CYP2D6 Activity. J Clin Pharmacol. 2022 Oct 30. doi: 10.1002/jcph.2169. [Epub ahead of print] — View Citation

Czuba LC, Fay EE, LaFrance J, Smith CK, Shum S, Moreni SL, Mao J, Isoherranen N, Hebert MF. Plasma Retinoid Concentrations Are Altered in Pregnant Women. Nutrients. 2022 Mar 25;14(7). pii: 1365. doi: 10.3390/nu14071365. — View Citation

Somani ST, Zeigler M, Fay EE, Leahy M, Bermudez B, Totah RA, Hebert MF. Changes in erythrocyte membrane epoxyeicosatrienoic, dihydroxyeicosatrienoic, and hydroxyeicosatetraenoic acids during pregnancy. Life Sci. 2021 Jan 1;264:118590. doi: 10.1016/j.lfs.2020.118590. Epub 2020 Oct 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CYP2D6 activity: dextromethorphan metabolic ratio	dextromethorphan metabolic ratio change from baseline during pregnancy	4 weeks