Patients with primary or secondary immunodeficiencies and/or patients who have an increased incidence of airborn infections more than 42 infectionsday /year.
Conditions
Interventions
Trade Name: Vigantol Oil
Product Name: Vigantol Oil
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: cholecalciferol
Concentration unit: mg/ml milligram(s)/millilitre
Pharmaceutical form
Sponsors
Karolinska University Hospital Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients (men and women) aged 18-75with a documented immunodeficiency order IgA IgG or subclass defiency as defined as: hypogammaglobulinemia AND a history of increased airborne infections > 42 days of infections /year 2. patient (men and women) 18-75 years old with an increased frequency of airborne infections i.e. > 42days of infection a year but with none of the above stated deficiencies. 3. patients who accepts to make a daily record of their infections diseasesnuances in a standarized questionnaire form ("infections diary") 4. plasma concentrations of 25 (OH) D3 vitamine D3 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. patients with less than 42 days of infections a year 2. patients has a ongoing antibiotic treatment 3. patients has clinical signs of hypercalcemia AND/OR verified hypercalcemia by biochemistry of hypercalcemia (>2.5mmol/L) 4. patients has clinical signs of change in parathyroidhormone (PTH >65ng/L) AND/OR verified by biochemistry 5. patients cannot fill in the infection questionnaire 6. patient are not expected to survive more than one year 7. patient has participated in another clinical trial within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if supplement of vitamine D3- to patients who suffers from immunodeficiencies or an increased frequency of infections -leads to a decreased frequency of airborne infections.;Secondary Objective: To investigate if vitamine D3 supplement also can lead to a local increase of immunoproteins in mucous membrane.;Primary end point(s): The frequency of airborne infections | — |
Countries
Sweden
Outcome results
None listed