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Effects of Retinoids on CYP2D6 Activity During Pregnancy

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ClinicalTrials.gov Identifier: NCT03117660
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Mary Hebert, University of Washington

Brief Summary:
Prospective drug interaction study during pregnancy.

Condition or disease Intervention/treatment Phase
CYP2D6 Polymorphism 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, 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 : July 25, 2017
Estimated Primary Completion Date : April 24, 2027
Estimated Study Completion Date : April 24, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

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



Primary Outcome Measures :
  1. CYP2D6 activity: dextromethorphan metabolic ratio [ Time Frame: 4 weeks ]
    dextromethorphan metabolic ratio change from baseline during pregnancy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy study
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117660


Contacts
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Contact: Mary F Hebert, PharmD 206-697-2138 mhebert@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Mary F Hebert, PharmD    206-697-2138    mhebert@uw.edu   
Sponsors and Collaborators
University of Washington
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Mary F Hebert, PharmD University of Washington

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Responsible Party: Mary Hebert, Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology, University of Washington
ClinicalTrials.gov Identifier: NCT03117660     History of Changes
Other Study ID Numbers: STUDY00001620
R01GM124264-01 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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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:
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Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents