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Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients with primary immunodeficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Vitamin D | Active Comparator | Vigantol (cholecalciferol) 4000 IE/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigantol | Drug | Vigantol 4000IU/day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Infectious score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antimicrobial peptide expression in nasal fluid | 12 months | |
| Serum levels of 25-OH Vitamin D3 | 12 months | |
| Consumption of antibiotics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Andersson, MD/PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Univerisity Hospital | Stockholm | 18146 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26419363 | Derived | Bergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation improves well-being in patients with frequent respiratory tract infections: a post hoc analysis of a randomized, placebo-controlled trial. BMC Res Notes. 2015 Sep 29;8:498. doi: 10.1186/s13104-015-1504-2. | |
| 26319134 | Derived | Bergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation to patients with frequent respiratory tract infections: a post hoc analysis of a randomized and placebo-controlled trial. BMC Res Notes. 2015 Aug 30;8:391. doi: 10.1186/s13104-015-1378-3. |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| Drug |
Placebo |
|
| 12 months |
| Number of positive bacterial cultures in nasal swabs | 12 months |