Immunological response of vitamin D

Immunological response of a single dose of 100,000 I.U. of cholecalciferol (vitamin D3)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003217-33-DE

Enrollment

Registered

2012-08-13

Start date

2013-02-04

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

relative vitamin D3 deficiency MedDRA version: 16.0 Level: LLT Classification code 10046242 Term: Unspecified vitamin D deficiency System Organ Class: 100000004861

Interventions

Trade Name: D3-Vicotrat Pharmaceutical Form: Solution for injection INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Current Sponsor code: Vitamin D3 Other descriptive name: D3-Vicotrat Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - written informed consent - men and women aged between 18 - 60 years - 25-hydroxyvitamin D3 serum concentration =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Main exclusion criteria - 25-hydroxyvitamin D3 serum concentration >50 nmol/l - BMI 30 kg/m² - regular or planned UV exposure - hypersensitivity against ingredients of the study drug - anamnesis: any disease which is a contraindication for the IMP - use of vitamin A or other vitamin D derivates - treatment with any medication which might interfere with the study drug or is an contra indication - pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to assess the impact of vitamin D3 on immune cells (frequency of CD38+ B-cells) in subjects with relative vitamin D3 deficiency after one injection of 100,000 I.U. either intramuscular or subcutaneous. ;Secondary Objective: Frequence of vitamin D3-responsive T-cells and myeloid antigen presenting cells carrying vitamin D3-sensitive surface markers. Immunological parameters (T-cell phenotype and cytokine profile, B-cell-phenotype, activation of monocytes, specific immunoglobulins) Pharmacokinetic Safety Tolerability;Primary end point(s): Frequency of CD38+ B-cells as pre-post comparison after vitamin D3 injection (i.m. or s.c.).;Timepoint(s) of evaluation of this end point: before as well as 7, 28 and 84 days after study drug application	—

Measure

Time frame

Main Objective: The main objective of the trial is to assess the impact of vitamin D3 on immune cells (frequency of CD38+ B-cells) in subjects with relative vitamin D3 deficiency after one injection of 100,000 I.U. either intramuscular or subcutaneous. ;Secondary Objective: Frequence of vitamin D3-responsive T-cells and myeloid antigen presenting cells carrying vitamin D3-sensitive surface markers. Immunological parameters (T-cell phenotype and cytokine profile, B-cell-phenotype, activation of monocytes, specific immunoglobulins) Pharmacokinetic Safety Tolerability;Primary end point(s): Frequency of CD38+ B-cells as pre-post comparison after vitamin D3 injection (i.m. or s.c.).;Timepoint(s) of evaluation of this end point: before as well as 7, 28 and 84 days after study drug application

—

Secondary

Measure	Time frame
Secondary end point(s): Frequency of vitamin D3-responsive T-cells and myeloid antigen presenting cells carrying vitamin D3-sensitive surface markers. Immunological parameters (T-cell cytokine profile, activation of monocytes, specific immunoglobulins) Pharmacokinetic Safety Tolerability;Timepoint(s) of evaluation of this end point: before as well as 7, 28 und 84 days after study drug application	—

Countries

Germany

Contacts

Public ContactAllergy-Center-Charité, CCM

Charité - Universitätsmedizin Berlin

sekretariat-worm@charite.de+4930450518092

Outcome results

None listed

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