VD-HCV: Long Term Vitamin D Therapy in HCV Treated Patients

Sponsor

Dr. Nadia AbdelAaty AbdelKader (Other)

Overall Status

Terminated

CT.gov ID

NCT01997203

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: Vitamin D	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Vitamin D vitamin D was given to 50 patients (HCV under treatment) Other Names: pegylated interferon ribavirin
No Intervention: HCV without Vit D

Arm

Intervention/Treatment

Experimental: 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

Drug: Vitamin D

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

Other Names:

pegylated interferon

ribavirin

No Intervention: HCV without Vit D

Outcome Measures

Primary Outcome Measures

composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tropical Medicine department, Bny swif university	Bny swif		Egypt
2	Medical biochemistry department, Cairo university	Cairo		Egypt

Sponsors and Collaborators

Dr. Nadia AbdelAaty AbdelKader

Investigators

Principal Investigator: Dina Sabry, Medical biochemistry, Cairo university
Study Chair: Mohamed M Tawfic, Tropical Medicine department, bny swif university
Study Chair: Yehia M Korriem, Tropical Medicine department, bny swif university
Study Chair: Nadia A Abdelkader, Tropical Medicine department, Ain Shams university
Study Chair: Amany Y Elkazaz, Medical Biochemistry, faculty of Medicine Suez Canal University
Study Chair: Mohamed Ghussin, Biochemistry department, faculty of Pharmacology Ghazza University.