A randomized placebo controlled trial of vitamin D3 supplementation to a vulnerable patientsgroup susceptible to uppertract respiratory infections.

Conditions: Patients with primary or secondary immunodeficiencies and/or patients who have an increased incidence of airborn infections more than 42 infectionsday /year.

Registration Number: EUCTR2009-011758-16-SE

Lead Sponsor: Karolinska University Hospital Huddinge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 < 175nM
5. signed informed consent
6. patients must be listed in the immunodefience unit for at least 1 year ahead

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

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