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

NCT01274013 | Withdrawn DMC

• 1 other identifier: ARI-1280-HEPC
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C; Chronic Hepatitis C; Vitamin D; Vitamin D deficiency

Outcome Measures

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.

  Initial clinic visit

Study Arms (2)

Study Group

Individuals with chronic Hepatitis C

Control Group

Healthy individuals

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Avera McKennan Hospital & University Health Center: lead

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (7)

• 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.

  PMID: 15860041 BACKGROUND

• 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.

  PMID: 15585789 BACKGROUND

• 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.

  PMID: 15798098 BACKGROUND

• 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.

  PMID: 17222588 BACKGROUND

• 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.

  PMID: 17420205 BACKGROUND

• 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.

  PMID: 15585785 BACKGROUND

• 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.

  PMID: 15776217 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Hesham Elgouhari, MD

  Avera McKennan Hospital & University Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 11, 2011
• Study Start: October 1, 2009
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)