Dietary supplement in chronic hepatitis C treatment

Evaluation of adding vitamin D to standard HCV regimen(PEG-interferon plus ribaverin) on early virologic response(EVR)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013112915581N1

Enrollment

Registered

2013-12-25

Start date

2014-01-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C. Chronic viral hepatitis C

Interventions

Intervention 1: Intervention group: D vitamin, Weekly, 1600 Unit a day, for 8 to 12 weeks. Then monthly to the end of treatment. Intervention 2: Control group: Standard diet, The standard die

Treatment - Drugs

Intervention group: D vitamin, Weekly, 1600 Unit a day, for 8 to 12 weeks. Then monthly to the end of treatment.

Control group: Standard diet, The standard diet in genotype 1 or 4 includes peginterferon a2a (180 mCg) together with (edible) ribavirin (800-1200 mg), the duration of the treatment is 48 weeks. The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major criteria to include in the study: The patients with hepatitis C who had not been under therapy were included in the study. Major criteria to exclude from the study: HIV patients; concurrent infection with hepatitis B and D; alcohol abuse; Wilson’s disease; hemochromatosis; decompensated cirrhosis, child score>9; patients with hepatocellular carcinoma; previous hepatitis C treatment; chronic kidney disorder; using antiepileptic drugs; history of vitamin D consumption (in the control group); pregnancy or breastfeeding; and steroid consumption.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
D Vitamin serum level. Timepoint: At the beginning of treatment and every three months to the end of treatment. Method of measurement: Blood Sampling.;Calcium serum level. Timepoint: At the beginning of treatment and every three months to the end of treatment. Method of measurement: Blood Sampling.	—

Secondary

Measure	Time frame
Quantification of HCV RNA. Timepoint: At weeks 4 and 12 during the treatment period for the assessment of RVR and EVR and at the end of treatment and 24 weeks after. Method of measurement: By Quantitative PCR.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Goshayeshi

Emam Reza Hospital

goshayeshil911@mums.ac.ir+98 51 1859 8818

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026