ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01274013
Recruitment Status : Suspended (Non Hep C study arm has been completed, Hep C study arm has not been completed.)
First Posted : January 11, 2011
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

January 7, 2011
January 11, 2011
June 27, 2017
October 2009
December 2018   (Final data collection date for primary outcome 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 ]
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.
Same as current
Complete list of historical versions of study NCT01274013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum
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.
Chronic Hepatitis C
Not Provided
  • Study Group
    Individuals with chronic Hepatitis C
  • Control Group
    Healthy individuals

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
100
Same as current
January 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01274013
ARI-1280-HEPC
Yes
Not Provided
Not Provided
Avera McKennan Hospital & University Health Center
Avera McKennan Hospital & University Health Center
Not Provided
Principal Investigator: Hesham Elgouhari, MD Avera McKennan Hospital & University Health Center
Avera McKennan Hospital & University Health Center
June 2017