Hepatitis immunisation and vitamin D supplementatio

Phase 1

Conditions: The effect of vitamin D supplementation on immune response following hepatitis B vaccine in incident and prevalent hemodialysis patients with vitamin D deficiency
MedDRA version: 14.1Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10019480Term: HemodialysisSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-004621-26-AT

Lead Sponsor: Medical University Graz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- incident and prevalent hemodialysis patients who have previously received no HBV-immunisation
- vitamin D3 level below 30 ng/ml
- aged >18 years
- estimated life expectancy >6 months
- written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- estimated life expectancy <6 months
- hypercacemia defined as a serrum calcium >2,7 mmol/L
- acute infection
- chronic diseases known to interfere with vitamin D intake or metabolism (such as inflammatory diseases with granuloma: Mb. Wegener, tuberculosis, sarcoidosis, inflammatory bowel disease)
- women in childbearing age

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this trial is to evaluate whether vitamin D supplementation is able to ameliorate the response of vitamin D-deficient hemodialysis patients receiving hepatitis B immunization;Secondary Objective: This study will further analyse the T-cell, B-cell and regulatory T-cell function of hemodialysis patients influenced by vitamin D supplementation and hepatitis vaccination;Primary end point(s): Changes in Anti-HbsAb-levels following a hepatitis B vaccination after vitamin D-supplementation in vitamin D-deficient hemodialysis patients;Timepoint(s) of evaluation of this end point: Anti-HbsAb-level measurement 2 weeks after the completion of the vaccination series (months 9-11)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effect of vitamin D supplementation on the immune status of hemodialysis patients;Timepoint(s) of evaluation of this end point: Immediately before vaccination and two month after completion of the vaccination