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Long Term Vitamin D Therapy in HCV Treated Patients

NCT ID: NCT01997203

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.

Detailed Description

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Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.

Conditions

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Chronic Hepatitis C

Keywords

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hepatitis C infection vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCV patients under treatment

Fifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D.

Dose of vitamin D 15,000 IU/week

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

vitamin D was given to 50 patients (HCV under treatment)

HCV without Vit D

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

vitamin D was given to 50 patients (HCV under treatment)

Intervention Type DRUG

Other Intervention Names

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pegylated interferon ribavirin

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV infection (positive HCV Ab more than 6 months)
* Treated with pegylated interferon and ribavirin

Exclusion Criteria

* Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus
* Previous non response to antiviral therapy.
* Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Nadia AbdelAaty AbdelKader

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nadia AbdelAaty AbdelKader

Ass. prof. Tropical Medicine - Ain Shams University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dina Sabry

Role: PRINCIPAL_INVESTIGATOR

Medical biochemistry, Cairo university

Mohamed M Tawfic

Role: STUDY_CHAIR

Tropical Medicine department, bny swif university

Yehia M Korriem

Role: STUDY_CHAIR

Tropical Medicine department, bny swif university

Nadia A Abdelkader

Role: STUDY_CHAIR

Tropical Medicine department, Ain Shams university

Amany Y Elkazaz

Role: STUDY_CHAIR

Medical Biochemistry, faculty of Medicine Suez Canal University

Mohamed Ghussin

Role: STUDY_CHAIR

Biochemistry department, faculty of Pharmacology Ghazza University.

Locations

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Tropical Medicine department, Bny swif university

Bny Swif, Bny Swif, Egypt

Site Status

Medical biochemistry department, Cairo university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HCV-VD2013

Identifier Type: -

Identifier Source: org_study_id