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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20161103003 |
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Date of registration:
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03/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Correction of vitamin D deficiency in chronic hepatitis C patients and effect on cytokines responses related to liver fibrotic pathway: A Randomized Double-Blind Placebo Control Study
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Scientific title:
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Correction of vitamin D deficiency in chronic hepatitis C patients and effect on cytokines responses related to liver fibrotic pathway: A Randomized Double-Blind Placebo Control Study |
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Date of first enrolment:
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01/11/2014 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20161103003 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 4
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Countries of recruitment
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thailand
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Contacts
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Name:
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piyawat
komolmit |
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Address:
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Faculty of medicine, chulalongkorn university
10330
bangkok
Thailand |
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Telephone:
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02-256-4356 |
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Email:
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namon_82@hotmail.com |
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Affiliation:
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Chulalongkorn unoversity |
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Name:
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piyawat
komolmit |
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Address:
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Faculty of medicine, chulalongkorn university
10330
bangkok
Thailand |
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Telephone:
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02-256-4356 |
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Email:
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namon_82@hotmail.com |
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Affiliation:
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Chulalongkorn unoversity |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Chronic hepatitis c or CHC cirrhosis child A
2. 25-OH vitamin D < 30 ng/ml
Exclusion criteria: 1. HIV, DM, chronic lung disease
2. other cause of chronic hepatitis
3. preganancy
4. active bacterial infection
5. immunosuppresive drug
6. GFR < 60
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic hepatitis C patient
liver fibrosis, chronic hepatitis C, vitamin D suppelment
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liver fibrosis, chronic hepatitis C, vitamin D suppelment
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Intervention(s)
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Active Comparator Drug,Placebo Comparator Drug
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Ergocalciferol (D2) 20,000 IU/ tab,Placebo tablet
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Vitamin D group,Placebo group
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Primary Outcome(s)
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matrixmetalloprotinase - 9 6 weeks after end of intervention Blood serum change
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Secondary Outcome(s)
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PDGF, TIMP1, IL22 and IFN-γ 6 weeks after end of intervention Blood serum change
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Source(s) of Monetary Support
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The Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
The Institutional review board of the the Faculty of medicine , Chulalongkorn university
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Results
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Results available:
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Date Posted:
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Date Completed:
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02/01/2016 |
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URL:
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