Chronic Hepatitis CNCT01274013
Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
An observational study of Chronic Hepatitis C, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
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.
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Chronic Hepatitis C, Vitamin D, Vitamin D deficiency
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Individuals with chronic Hepatitis C | |
| Control Group | Healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2018
- Study completionJan 2019 (estimated)
Why it stopped: Non Hep C study arm has been completed, Hep C study arm has not been completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesham Elgouhari, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274013
- Sponsor's protocol ID
- ARI-1280-HEPC
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2011
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 15860041DeLuca 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 15585789Nagpal 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 15798098Fisher 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 17222588Yano 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 17420205Boucher 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 15585785Dawson-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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01274013
- Acronym / sponsor ID
- ARI-1280-HEPC
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Chronic Hepatitis C, Vitamin D, Vitamin D deficiency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Non Hep C study arm has been completed, Hep C study arm has not been completed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (estimated)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Individuals with chronic Hepatitis C |
| Control Group | – | –Healthy individuals |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Initial clinic visit
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Background: PubMed 15860041Peterlik 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.
- Background: PubMed 15585789DeLuca 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.
- Background: PubMed 15798098Nagpal 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.
- Background: PubMed 17222588Fisher 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.
- Background: PubMed 17420205Yano 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.
- Background: PubMed 15585785Boucher 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.
- Background: PubMed 15776217Dawson-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham Elgouhari, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Initial clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274013, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.