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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01274013
First received: January 7, 2011
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition
Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
Individuals with chronic Hepatitis C
Control Group
Healthy individuals

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274013

Locations
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Hesham Elgouhari, MD Avera McKennan Hospital & University Health Center
  More Information

Additional Information:
Publications:
Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01274013     History of Changes
Other Study ID Numbers: ARI-1280-HEPC
Study First Received: January 7, 2011
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
Hepatitis C
Chronic Hepatitis C
Vitamin D
Vitamin D deficiency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Vitamin D Deficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 16, 2014