Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
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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 |
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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 |
- 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 |
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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.
Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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
Contact: Vicki Munson, RN | (605) 322-3087 | vicki.munson@avera.org |
Contact: Jayden Portice | (605) 322-3054 | jayden.portice@avera.org |
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 |
Principal Investigator: | Hesham Elgouhari, MD | Avera McKennan Hospital & University Health Center |
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: | 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 Hepatitis A Hepatitis, Chronic Hepatitis C Vitamin D Deficiency Hepatitis C, Chronic 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 October 18, 2012