Immunologic Action of a Single Dose Cholecalciferol

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Margitta Worm
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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