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Trial record 11 of 179 for:    Phospholipids

Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability

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ClinicalTrials.gov Identifier: NCT01957319
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Mariano Malaguarnera, University of Catania

Brief Summary:

Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life.

Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.

Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).


Condition or disease Intervention/treatment Phase
Work Ability Depression Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg Drug: sugar pill Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability
Study Start Date : February 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E
Drug Information available for: Vitamin E

Arm Intervention/treatment
Active Comparator: Silybin - vitamin E - phospholipids complex
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months.
Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg
Placebo Comparator: placebo
sugar pill
Drug: sugar pill



Primary Outcome Measures :
  1. Work ability index [ Time Frame: 12 months ]
    Administration of questionnaire(Work ability Index - WAI)The work ability index is a tool to record the work ability of employees. It aims at identifying, at an early stage, health risks of early retirement an counteracting them. The questionnaire is aimed at: 1) the estimated current and future work ability; 2) diagnosed illness and the number of absenteeism days in the previous year; 3) the estimated sickness-related deterioration in the work performance; 4) mental ability reserves. The WAI evaluates current work ability compared with lifetime and in relation to the demands of the job, number of current diseases diagnosed by a physician, estimated work impairment due to diseases.


Secondary Outcome Measures :
  1. depression [ Time Frame: 12 months ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV infection

Exclusion Criteria:

  • cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy hemoglobinopathies hemocromatosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957319


Locations
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Italy
University of Catania, Cannizzaro Hospital
Catania, Italy, 95125
Sponsors and Collaborators
University of Catania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mariano Malaguarnera, Associate Professor, University of Catania
ClinicalTrials.gov Identifier: NCT01957319     History of Changes
Other Study ID Numbers: 12/1997
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Interferons
Silybin
Ribavirin
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Antineoplastic Agents, Phytogenic