Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Sponsor Avera McKennan Hospital & University Health Center
Start date October 2009
End date December 2018
Trial size 100 participants
Trial identifier NCT01274013, ARI-1280-HEPC

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Individuals with chronic Hepatitis C
Healthy individuals

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
Principal investigator Hesham Elgouhari, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Avera McKennan Hospital & University Health Center.