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

NCT ID: NCT01274013

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Individuals with chronic Hepatitis C

No interventions assigned to this group

Control Group

Healthy individuals

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Men and women between the ages of 25 and 55
* Diagnosis of chronic hepatitis C


* Men and women between the ages of 20 and 60
* Has a body mass index (BMI) between 20 and 35

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hesham Elgouhari, MD

Role: PRINCIPAL_INVESTIGATOR

Avera McKennan Hospital & University Health Center

Locations

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Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15860041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15585789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15798098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17222588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17420205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15585785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15776217 (View on PubMed)

Other Identifiers

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ARI-1280-HEPC

Identifier Type: -

Identifier Source: org_study_id

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