Orange Juice Consumption in Patients With Hepatitis C

Sponsor

São Paulo State University (Other)

Overall Status

Completed

CT.gov ID

NCT03026569

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C, may contribute to the treatment of patients with chronic hepatitis C.

Condition or Disease	Intervention/Treatment	Phase
Chronic Infection	Other: Orange juice (500 mL/d)	N/A

Detailed Description

Forty-three patients with chronic hepatitis C who were being treated with pegylated interferon combined with ribavirin, according to the Clinical Protocol and Therapeutic Guidelines for Viral Hepatitis C and Co-infections of the Brazilian Health Ministry were randomly divided into two parallel groups: (1) orange juice (n = 23), which were supplemented with orange juice (500 mL/d) for 8 weeks; (2) control group (n = 20) composed of patients that were not drinking orange juice regularly. The recruitment process began in February 2012, the intervention was carried out from May 2012 to July 2012, and the data analysis started in September 2012. The sample number took into account variances on total cholesterol with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Dourado et al., 2015). The minimum sample size should have 20 individuals per group (n = 40), considering an approximately 15% dropout rate. Primary and secondary endpoints were the reduction of total cholesterol and modification of biochemical markers, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. Assessment of the data was performed in all participants on the first and last day of the experiment. All the parameters were compared between the juice group and the control group using General Linear Model of Repeated Measures Analysis. Differences in baseline patients' characteristics between the two groups were analyzed by One-way analysis of variance (ANOVA). The LSD signed rank post-test was used to assess significant changes in parameters after the start of treatment in each group, and the differences were considered statistically significant at p < 0.05.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orange juice Orange juice: twenty-three patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were supplemented with 100% commercial pasteurized orange juice (500 mL/d) during 8 weeks.	Other: Orange juice (500 mL/d) The patients were instructed to drink orange juice in two daily portions during eight consecutive weeks. Patients from both groups were asked to maintain their usual lifestyle, diet, and physical activity, and they were checked weekly by the researcher's team. Assessments of anthropometric data, dietary intake, as well as blood sample collection for biochemical analysis were performed in all participants on the first and last day of the experiment.
No Intervention: Control Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks.

Arm

Intervention/Treatment

Experimental: Orange juice

Orange juice: twenty-three patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were supplemented with 100% commercial pasteurized orange juice (500 mL/d) during 8 weeks.

Other: Orange juice (500 mL/d)

The patients were instructed to drink orange juice in two daily portions during eight consecutive weeks. Patients from both groups were asked to maintain their usual lifestyle, diet, and physical activity, and they were checked weekly by the researcher's team. Assessments of anthropometric data, dietary intake, as well as blood sample collection for biochemical analysis were performed in all participants on the first and last day of the experiment.

No Intervention: Control

Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks.