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JAPANESE
国立保健医療科学院
UMIN ID: UMIN000004947

Registered date:01/02/2011

An open-label randomized controlled study on the efficacy and safety of vitamin D plus peginterferon alpha 2a/ribavirin in elder women with chronic hepatitis C

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedWomen with chronic hepatitis C genotype 1 older than 60 years old
Date of first enrollment2011/02/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Alphacalcidol (1.0 microgram/day) for 4 weeks before alphacalcidol (1.0 microgram/day) plus peginterferon alpha 2a/ribavirin for 48-72 weeks Peginterferon alpha 2a/ribavirin for 48-72 weeks

Outcome(s)

Primary OutcomeViological response
Secondary OutcomeRelationship between serum vitamin D and vuiological response Safety and effectiveness

Key inclusion & exclusion criteria

Age minimum60years-old
Age maximumNot applicable
GenderFemale
Include criteria
Exclude criteriaPatients are excluded if they have decompensated liver diseases, other causes of liver diseases, hepatitis B infection, hemoglobin values <12 g/dl, white blood cell count <3000/ul, thrombocytopenia <90,000/ul, neoplastic, severe cardiac, neurological, autoimmune or thyroid diseases. Also excluded were patients with alcohol or drug abuse, women who were pregnant or considering pregnancy in the next 18 months, or men whose partners were considering pregnancy in the next 18 months.

Related Information

Contact

public contact
Name Masahito Nagaki
Address 1-1 Yanagido, Gifu 501-1194, Japan Japan
Telephone 058-230-6308
E-mail
Affiliation Gifu University Graduate School of Medicine Department of Gastroenterology
scientific contact
Name Masahito Nagaki
Address 1-1 Yanagido, Gifu 501-1194, Japan Japan
Telephone 058-230-6308
E-mail
Affiliation Gifu University Graduate School of Medicine Department of Gastroenterology