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

• ClinicalTrials.gov Identifier: NCT02120274
• Recruitment Status: Terminated
• First Posted: April 22, 2014
• Last Update Posted: August 24, 2016
• Sponsor: Federal University of São Paulo
• Information provided by (Responsible Party): Henrique Pott Junior, Federal University of São Paulo

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic	Drug: Vitamin D; Drug: Vitamin B 12	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: March 2014
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; Pegylated Interferon-Alfa plus ribavirin for 48 weeks
Experimental: Vitamins; Pegylated Interferon-Alfa plus ribavirin for 48 weeks together oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level. Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.	Drug: Vitamin D; Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.; Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. SVR12 [ Time Frame: 12 weeks after treatment completion ]
   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.

Secondary Outcome Measures :

1. RVR, EVR, EOT [ Time Frame: week 4, week 12 and at the end-of-treatment. ]
   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);

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Brazil

Outpatient Clinic of Viral Hepatitis (NUPAIG)

São Paulo, Brazil, 04025-001

Sponsors and Collaborators

Federal University of São Paulo

Investigators

• Study Director: Adauto Castelo, PhD; Federal University of São Paulo
• Study Chair: Jorge F Senise, PhD; Federal University of São Paulo

More Information

• Responsible Party: Henrique Pott Junior, Dr. Henrique Pott-Junior, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT02120274
• Other Study ID Numbers: DB12SHCV; U1111-1155-6986 ( Other Identifier: Universal Trial Number )
• First Posted: April 22, 2014
• Last Update Posted: August 24, 2016
• Last Verified: August 2016

Keywords provided by Henrique Pott Junior, Federal University of São Paulo:

RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic; Vitamin D; Cholecalciferol; Vitamin B 12

Additional relevant MeSH terms:

Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; RNA Virus Infections; Flaviviridae Infections; Hepatitis; Disease Attributes; Pathologic Processes; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Blood-Borne Infections; Hepatitis, Chronic; Vitamin D; Vitamins; Vitamin B 12; Hydroxocobalamin; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Vitamin B Complex; Hematinics