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NCT01274013 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

Official title:
A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01274013
Other study ID # ARI-1280-HEPC
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 2009
Est. completion date January 2019

Study information
Verified date January 2019
Source Avera McKennan Hospital & University Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Avera Research Institute Sioux Falls South Dakota

Sponsors (1)
Lead Sponsor Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. Epub 2005 Mar 18. — View Citation

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. Review. — View Citation

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. Epub 2007 Jan 10. — View Citation

Nagpal S, Na S, Rathnachalam R. Noncalcemic actions of vitamin D receptor ligands. Endocr Rev. 2005 Aug;26(5):662-87. Epub 2005 Mar 29. Review. — View Citation

Peterlik M, Cross HS. Vitamin D and calcium deficits predispose for multiple chronic diseases. Eur J Clin Invest. 2005 May;35(5):290-304. Review. — View Citation

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. Epub 2007 Apr 9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Initial clinic visit
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