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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01274013

Enrollment

Registered

2011-01-11

Start date

2009-10-31

Completion date

2019-01-31

Last updated

2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C, Chronic Hepatitis C, Vitamin D, Vitamin D deficiency

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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	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.

Countries

United States

Outcome results