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Effects of Retinoids on CYP2D6 Activity During Pregnancy

Sponsor
University of Washington (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03117660
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH)
100
Enrollment
1
Location
2
Arms
117
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective drug interaction study during pregnancy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin A
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomized, parallel group studyProspective, randomized, parallel group study
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations
Actual Study Start Date :
Jul 25, 2017
Anticipated Primary Completion Date :
Apr 24, 2027
Anticipated Study Completion Date :
Apr 24, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin A

Subjects will receive 3-4weeks of vitamin A

Drug: Vitamin A
vitamin A daily X3-4 weeks
No Intervention: Control

Subjects will receive no treatment

Outcome Measures

Primary Outcome Measures

  1. CYP2D6 activity: dextromethorphan metabolic ratio [4 weeks]

    dextromethorphan metabolic ratio change from baseline during pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington
  • National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Mary F Hebert, PharmD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mary Hebert, Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology, University of Washington
ClinicalTrials.gov Identifier:
NCT03117660
Other Study ID Numbers:
  • STUDY00001620
  • R01GM124264-01
First Posted:
Apr 18, 2017
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Vitamin A

Study Results

No Results Posted as of Sep 29, 2021