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

This study is currently recruiting participants.
Verified May 2012 by Avera McKennan Hospital & University Health Center
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01274013
First received: January 7, 2011
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

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: September 2013
Estimated Primary Completion Date: September 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274013

Contacts
Contact: Vicki Munson, RN (605) 322-3087 vicki.munson@avera.org
Contact: Jayden Portice (605) 322-3054 jayden.portice@avera.org

Locations
United States, South Dakota
Avera Research Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Vicki Munson, RN     605-322-3087     vicki.munson@avera.org    
Principal Investigator: Hesham Elgouhari, MD            
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:
Avera Research Institute website  This link exits the ClinicalTrials.gov site

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: May 31, 2012
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 C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, 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
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 13, 2013