Immunologic Action of a Single Dose Cholecalciferol (ViDImmun)

Margitta Worm

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency

Treatments: Drug: Placebo; Drug: single administration of 100.000 I.U. vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01845142

2012-003217-33 (EudraCT Number)

ViDImmun

Details and patient eligibility

About

Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.

Full description

Vitamin D-deficient individuals will receive once

• double-blind, placebo controlled 100.000 I.U.vitamin D3
• intramuscular or subcutaneous

Blood will be taken over time and

• immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by flow-cytometry
• vitamin D-metabolites will be monitored

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• informed consent
• 18-60 yrs
• 25-hydroxyvitamin D serum below 50 nmol/L
• women only: effective contraception

Exclusion criteria

• 25-hydroxyvitamin D serum above 50 nmol/L
• body-mass index <18 or >30 kg per m2
• planned UV-exposure (UV-index > 5)
• hypersensitivity to vitamin D
• history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin A- and/or vitamin D treatment
• treatment with immunosuppressants, immunomodulators, phenytoin, barbiturate, thiazide-diuretics, glycosides
• immobile patients
• out of normal range on screening visit (calcium,phosphate,creatinin,hematology)
• psychiatric hospitalization
• pregnancy / breast-feeding
• dependency / relationship on sponsor
• concomitant participation in other clinical trials (30 days before)
• drug or alcohol abuse
• lack of compliance

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

intramuscular 100.000 I.U. vitamin D3

Active Comparator group

Description:

intramuscular 100.000 I.U. vitamin D3

Treatment:

Drug: single administration of 100.000 I.U. vitamin D

intramuscular placebo

Placebo Comparator group

Description:

intramuscular 0.9% sodium chloride

Treatment:

Drug: Placebo

subcutaneous 100.000 I.U. vitamin D3

Active Comparator group

Description:

subcutaneous 100.000 I.U. vitamin D3

Treatment:

Drug: single administration of 100.000 I.U. vitamin D

subcutaneous placebo

Placebo Comparator group

Description:

subcutaneous 0.9% sodium chloride

Treatment:

Drug: Placebo