Hepatitis immunisation and vitamin D supplementation

The effect of vitamin D supplementation on immune response following hepatitis B vaccine in incident and prevalent hemodialysis patients with vitamin D deficiency - Devitahep

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004621-26-AT

Enrollment

Unknown

Registered

2012-05-03

Start date

2012-07-31

Completion date

Unknown

Last updated

2016-07-04

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

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: 14.1 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10019480 Term: Hemodialysis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Class

Interventions

Trade Name: Oleovit D3 Tropfen Product Name: Oleovit D3 Tropfen Pharmaceutical Form: Oral drops Current Sponsor code: SUB11818MIG Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - estimated life expectancy 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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactSabine Horn

Medical University Graz

sabine.horn@medunigraz.at004331638512170

Outcome results

None listed

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