Clinical trial NCT01274013: Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
Official title: A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C
Chronic Hepatitis C
Vitamin D
Vitamin D deficiency
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

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

Primary outcomes:
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
timeFrame: Initial clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Hesham Elgouhari, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1365-2362.2005.01487.x.
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.
citation: 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.
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. doi: 10.1016/j.cgh.2006.10.015. Epub 2007 Jan 10.
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. doi: 10.1128/AAC.01426-06. Epub 2007 Apr 9.
citation: 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.
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. doi: 10.1007/s00198-005-1867-7. Epub 2005 Mar 18.