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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03117660
Other study ID # STUDY00001620
Secondary ID R01GM124264-01
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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