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Identification of Markers for Determining the Efficacy of Vitamin D Receptor Activator Therapy in Stage 3/4 CKD Patients

NCT02018133 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2020-08-17

No results posted yet for this study

Summary

The purpose of this study is to identify genes that are responsive to paricalcitol (active vitamin D) therapy. Scientists have found that over 30 different types of cells in the body respond to vitamin D therapy, including blood vessels. Low levels of vitamin D may reduce the amount of calcium in the blood, increase the amount of parathyroid hormone (PTH) and cause the parathyroid gland (small gland located in the neck) to get bigger which is called secondary hyperparathyroidism (SHPT). Also, low levels of vitamin D may worsen the heart disease seen in dialysis patients. Paricalcitol, a man-made active vitamin D, is a replacement for vitamin D for preventing and treating SHPT. Studies that followed patients on dialysis have found: (1) differences in death rates between those who received active vitamin D compared with no activated vitamin D, and (2) a survival benefit in chronic kidney disease (CKD) patients receiving paricalcitol, over calcitriol (natural active vitamin D). Researchers have considered that giving paricalcitol to people with (CKD) may also prevent or slow the progression of heart disease.

Currently, physicians can only tell how well the vitamin D is working by measuring PTH concentrations. This study aims to identify markers in the blood that can be used to determine the efficacy of Vitamin D therapy.

Conditions

  • CKD Stage 3/4

Interventions

DRUG

Vitamin D 2mg daily for 2 weeks oral paricalcitol

vitamin D 2 capsules daily

DRUG

Placebo

placebo 2 capsule daily

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Alan Lau, PharmD · University of Illinois at Chicago

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02018133 on ClinicalTrials.gov