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WithdrawnNCT01274013Updated Jan 10, 2019

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

An observational study in Chronic Hepatitis C, sponsored by Avera McKennan Hospital & University Health Center. Withdrawn at 1 site in United States. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-10.

Sponsored by Avera McKennan Hospital & University Health Center · Observational

Why this study was withdrawn
Non Hep C study arm has been completed, Hep C study arm has not been completed.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
20 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic Hepatitis C

Keywords

  • Hepatitis C
  • Chronic Hepatitis C
  • Vitamin D
  • Vitamin D deficiency
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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

Browse Hepatitis A studies →

Lead sponsor

Avera McKennan Hospital & University Health Center is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
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.

Eligibility 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Study Group

    Individuals with chronic Hepatitis C

  • Control Group

    Healthy individuals

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What researchers measure

Primary outcomes

  1. 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

    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.

    Time frame: Initial clinic visit

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Study locations

1 site
  • Avera Research Institute
    Sioux Falls, South Dakota 57105, United States
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References and documents

Publications

  • Peterlik M, Cross HS. Vitamin D and calcium deficits predispose for multiple chronic diseases. Eur J Clin Invest. 2005 May;35(5):290-304. doi: 10.1111/j.1365-2362.2005.01487.x. PubMed 15860041 ↗
  • DeLuca HF. Overview of general physiologic features and functions of vitamin D. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1689S-96S. doi: 10.1093/ajcn/80.6.1689S. PubMed 15585789 ↗
  • Nagpal S, Na S, Rathnachalam R. Noncalcemic actions of vitamin D receptor ligands. Endocr Rev. 2005 Aug;26(5):662-87. doi: 10.1210/er.2004-0002. Epub 2005 Mar 29. PubMed 15798098 ↗
  • Fisher L, Fisher A. Vitamin D and parathyroid hormone in outpatients with noncholestatic chronic liver disease. Clin Gastroenterol Hepatol. 2007 Apr;5(4):513-20. doi: 10.1016/j.cgh.2006.10.015. Epub 2007 Jan 10. PubMed 17222588 ↗
  • Yano M, Ikeda M, Abe K, Dansako H, Ohkoshi S, Aoyagi Y, Kato N. Comprehensive analysis of the effects of ordinary nutrients on hepatitis C virus RNA replication in cell culture. Antimicrob Agents Chemother. 2007 Jun;51(6):2016-27. doi: 10.1128/AAC.01426-06. Epub 2007 Apr 9. PubMed 17420205 ↗
  • Boucher BJ, John WG, Noonan K. Hypovitaminosis D is associated with insulin resistance and beta cell dysfunction. Am J Clin Nutr. 2004 Dec;80(6):1666; author reply 1666-7. doi: 10.1093/ajcn/80.6.1666. No abstract available. PubMed 15585785 ↗
  • Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporos Int. 2005 Jul;16(7):713-6. doi: 10.1007/s00198-005-1867-7. Epub 2005 Mar 18. PubMed 15776217 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01274013
Lead sponsor
Avera McKennan Hospital & University Health Center
Responsible party
Sponsor
First posted
Jan 11, 2011
Start date
Oct 2009
Primary completion
Dec 2018
Completion
Jan 2019 (estimated)
Last update
Jan 10, 2019

Study contacts

Hesham Elgouhari, MD
principal investigator · Avera McKennan Hospital & University Health Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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