Methicillin Resistant Staphylococcus Aureus, Vitamin D3 Deficiency
Conditions
Brief summary
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.
Interventions
DRUGCholecalciferol
Cholecalciferol 4000 IU/day for 12 months
OTHERPlacebo
Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months
Sponsors
Peter Bergman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Persistent MRSA-carriers as defined as 2 MRSA-positive bacterial cultures from at least one location, at least 3 months apart and during 3 years prior to inclusion. 2. Men and women aged ≥18-75 3. Signed 'informed consent' 4. Negative pregnancy test (U-hcg) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral).
Exclusion criteria
1. Should not be on vitamin D supplementation at least 6 months prior to inclusion. 2. Serum level of 25-hydroxy vitamin D3 \>75 nmol/L 3. Ongoing and continuous antibiotic treatment. The patient should be off antibiotics at least 30 days prior to inclusion 4. Known sarcoidosis 5. Primary or secondary hyperparathyroidism 6. Kidney failure as defined as a normal age-adjusted creatinin. 7. Long term systemic treatment with corticosteroids or other immunosuppressive medication 8. Taking thiazides 9. Hypercalcaemia (verified by a laboratory result younger than 2 month) 10. Ongoing malignancy disorder 11. If plans to leave the Stockholm county within 12 months of inclusion 12. History of kidney stones 13. Pregnancy (ongoing or planned) 14. Breastfeeding women 15. Taking part of another clinical study involving drugs 16. Hypersensitivity to cholecalciferol and/or any of the excipients 17. Other criteria that could jeopardize the study or its intention as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRSA | Baseline, 3, 6, 9 and 12 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Vitamin D levels in serum | baseline, 3, 6, 9, 12, 18 and 24 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patterns of DNA methylation in immune cells | baseline, 3,6, 9, 12, 18 and 24 months | 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. |
| Changes in microflora in the intestinal and nasal tracts | Baseline, 9, 12 and 24 month | — |
Countries
Sweden
Outcome results
None listed