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The purpose of this study is to treat persistent MRSA carriers with vitamin D supplementation during a 12 month to see if the number of MRSA positive patients can be reduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Active Comparator | 150 patients with MRSA resistent Cholecalciferol 4000 international units (IU)/day for 12 month |
|
| Sugarpill | Placebo Comparator | 150 patients with MRSA resistent Placebo daily 12 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Cholecalciferol 4000 IU/day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRSA | The primary endpoint is the decline of MRSA-positive patients during a 12-month period in the treatment groups (vitamin D/Placebo) based on 5 measurements with 3 months interval. | Baseline, 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D levels in serum | baseline, 3, 6, 9, 12, 18 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of DNA methylation in immune cells | Total DNA from whole blood will be isolated and analysed for methylation patterns using the bisulphite exchange method. Focus will be on methylation in genes related to vitamin D metabolism and immunity, including cytochrome p450 number 24 (CYP24), cytochrome p450 number 27 (CYP27) and cathelicidin antimicrobial peptide (CAMP) genes. | baseline, 3,6, 9, 12, 18 and 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gudrun Lind, M.D PhD | Karolinska University Hospital, Solna. Department of Infectious Diseases | Principal Investigator |
| Peter Bergman, M.D PhD | Karolinska University Hospital Huddinge, Department of Infectious Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Huddinge | SE_ 141 86 | Sweden | ||
| Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23242238 | Background | Bergman P, Norlin AC, Hansen S, Rekha RS, Agerberth B, Bjorkhem-Bergman L, Ekstrom L, Lindh JD, Andersson J. Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study. BMJ Open. 2012 Dec 13;2(6):e001663. doi: 10.1136/bmjopen-2012-001663. Print 2012. | |
| 20210515 |
| Label | URL |
|---|---|
| A report on a previous study where vitamin D/Placebo was given to patients with frequent respiratory tract infections. | View source |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Other | Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months |
|
| Changes in microflora in the intestinal and nasal tracts | Baseline, 9, 12 and 24 month |
| Stockholm |
| Solna |
| SE- 171 76 |
| Sweden |
| Matheson EM, Mainous AG 3rd, Hueston WJ, Diaz VA, Everett CJ. Vitamin D and methicillin-resistant Staphylococcus aureus nasal carriage. Scand J Infect Dis. 2010 Jul;42(6-7):455-60. doi: 10.3109/00365541003602049. |
| 21263449 | Background | Hewison M. Antibacterial effects of vitamin D. Nat Rev Endocrinol. 2011 Jun;7(6):337-45. doi: 10.1038/nrendo.2010.226. Epub 2011 Jan 25. |
| 30157946 | Derived | Bjorkhem-Bergman L, Torefalk E, Ekstrom L, Bergman P. Vitamin D binding protein is not affected by high-dose vitamin D supplementation: a post hoc analysis of a randomised, placebo-controlled study. BMC Res Notes. 2018 Aug 29;11(1):619. doi: 10.1186/s13104-018-3725-7. |
| 29931657 | Derived | Bjorkhem-Bergman L, Missailidis C, Karlsson-Valik J, Tammelin A, Ekstrom L, Bottai M, Hammar U, Lindh G, Bergman P. Vitamin D supplementation to persistent carriers of MRSA-a randomized and placebo-controlled clinical trial. Eur J Clin Microbiol Infect Dis. 2018 Sep;37(9):1735-1744. doi: 10.1007/s10096-018-3306-7. Epub 2018 Jun 21. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |