Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C

Hepatitis C Clinical Trial

Official title:

Randomized Clinical Trial to Assess the Effectiveness of Vitamin D and Vitamin B12 Supplementation in Combination With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02120274
• Other study ID #: DB12SHCV
• Secondary ID: U1111-1155-6986
• Status: Terminated
• Phase: Phase 4
• First received: April 18, 2014
• Last updated: August 23, 2016
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.

Description:

Randomized clinical trial comparing rates of RVR, eRVR, EOT and SVR during standard treatment with Pegylated Interferon-Alfa plus Ribavirin compared to the same treatment supplemented with B12 and vitamin D during the treatment period.

Patients assigned to the vitamin supplementation group will receive the standard treatment of Pegylated Interferon-Alfa plus Ribavirin for 48 weeks together oral Vitamin D and intramuscular Vitamin B12. The control group will receive the same regimen of peguilated alfainterferon plus ribavirin for 48 weeks without any vitamin supplementation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR

• Pegylated Interferon-Alfa treatment naïve

• Liver biopsy with Metavir F2 or less

• Cognitive capacity to understand and sign the informed consent

Exclusion Criteria:

• HBV or HIV co-infection

• Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3

• Creatinin = 1.5 mg/dL

• Severe cardiopathy

• Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding

• Conditions that, according to the investigator's judgement, preclude participation in the study, including clinical, cognitive or behavioural conditions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Flaviviridae Infections
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• RNA Virus Infections
• Virus Diseases

Intervention

Drug:
• Vitamin D
Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.
• Vitamin B 12
Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.

Locations

Country	Name	City	State
Brazil	Outpatient Clinic of Viral Hepatitis (NUPAIG)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	Proportion of patients with SVR, defined as HCV RNA bellow the limit of detection 12 weeks after treatment completion with peguilated alfainterferon-2B plus ribavirin, with or without vitamin supplementation.	12 weeks after treatment completion	No
Secondary	RVR, EVR, EOT	Proportion of patients presenting HCV RNA bellow the limit of detection at week 4 (RVR), week 12 (EVR - early virological response) and at the end-of-treatment (EOT);	week 4, week 12 and at the end-of-treatment.	No