Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

January 9, 2019 updated by: Avera McKennan Hospital & University Health Center

A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

The objective of this study is to assess the prevalence of vitamin D deficiency in patients with chronic Hepatitis C compared to a matched control group of healthy individuals in the Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more common in patients with chronic Hepatitis C compared to the healthy control group.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

In this study, we will measure vitamin D levels in patients with chronic Hepatitis C and healthy individuals. This study will be important to assess vitamin D inadequacy in patients with chronic Hepatitis C and healthy individuals in this area.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a comparison study between two different populations: a study group and a control group. The study group will consist of fifty individuals with a diagnosis of chronic Hepatitis C. The control group will consist of fifty individuals who are considered to be generally healthy.

Description

Inclusion Criteria for Study Group:

  • Men and women between the ages of 25 and 55
  • Diagnosis of chronic hepatitis C

Exclusion Criteria for Study Group:

  • Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates
  • Has acute hepatitis C infection
  • Has chronic hepatitis B infection
  • Had gastric bypass surgery
  • Has chronic kidney disease

Inclusion Criteria for Control Group:

  • Men and women between the ages of 20 and 60
  • Has a body mass index (BMI) between 20 and 35

Exclusion Criteria for Study Group:

  • Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates
  • Has any significant illness or medical problem that is not under control or being controlled by medication
  • History of hepatitis or abnormal liver chemistry tests
  • History of intravenous drug use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Group
Healthy individuals
Study Group
Individuals with chronic Hepatitis C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Vitamin D levels of the 100 subjects will be statistically analyzed as the primary variable and correlated with the rest of the variables via ANOVA and meta-analysis
Time Frame: Initial clinic visit
This research study consists of a single clinic visit. After study subjects have completed the informed consent process and are determined to meet study eligibility, a blood sample will be collected. Values from these lab samples will be compared between study arms.
Initial clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avera McKennan Hospital & University Health Center

Investigators

  • Principal Investigator: Hesham Elgouhari, MD, Avera McKennan Hospital & University Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARI-1280-HEPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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