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Drug Metabolizing Enzyme and Transporter Function in Chronic Kidney Disease

NCT02360644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-06-30

No results posted yet for this study

Summary

This study investigates the effect of vitamin D deficiency on drug metabolism and transport in patients with chronic kidney disease (CKD) and in healthy controls.

The central hypothesis is that vitamin D concentrations independently affect metabolism and transport function in CKD patients. An over-arching goal of this proposal is to make drug therapies safer and more effective to reduce the significant morbidity and mortality in patients with CKD.

Conditions

  • Chronic Kidney Diseases
  • Deficiency, Vitamin D

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

Vitamin D deficient patients, in both Arms, will be administered Cholecalciferol 5,000 IU daily.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Melanie Joy, PharmD, PhD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-02-01
Completion
2019-02-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360644 on ClinicalTrials.gov