NCT03117660

Brief Summary

Prospective drug interaction study during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

5.3 years

First QC Date

April 10, 2017

Last Update Submit

November 1, 2022

Conditions

CYP2D6 Polymorphism

Outcome Measures

Primary Outcomes (1)

  • CYP2D6 activity: dextromethorphan metabolic ratio

    dextromethorphan metabolic ratio change from baseline during pregnancy

    4 weeks

Study Arms (2)

Vitamin A

EXPERIMENTAL

Subjects will receive 3-4weeks of vitamin A

Drug: Vitamin A

Control

NO INTERVENTION

Subjects will receive no treatment

Interventions

Vitamin ADRUG

vitamin A daily X3-4 weeks

Vitamin A

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy study
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancies
  • Extensive metabolizers

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • 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.

    PMID: 33069736BACKGROUND

  • 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. 2023 Mar;63(3):363-372. doi: 10.1002/jcph.2169. Epub 2022 Nov 15.

    PMID: 36309846BACKGROUND

  • 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):1365. doi: 10.3390/nu14071365.

    PMID: 35405978BACKGROUND

MeSH Terms

Interventions

Vitamin A

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Mary F Hebert, PharmD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Prospective, randomized, parallel group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 18, 2017

Study Start

July 25, 2017

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

The investigators will adhere to the NIH Grant Policy on Sharing Research Data. That is, after final data collection and analysis and after full peer review is performed on the data, the de-identified data generated by this project will be made available when requested by the academic community and researchers-at-large contingent upon Material Transfer Agreements with the University of Washington.

Locations

US(1)