Efficacy Study of Vitamin D Supplementation to Meticillin Resistant Staphylococcus Aureus (MRSA) Carriers
This trial is active, not recruiting.
|Conditions||resistant staphylococcus aureus: [methicillin] or [multiple], cholecalciferol toxicity, staphylococcus aureus infections|
|Start date||December 2014|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT02178488, D-STAPH-EXT-01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: Baseline, 3, 6, 9 and 12 months
Vitamin D levels in serum
time frame: baseline, 3, 6, 9, 12, 18 and 24 months
Male or female participants from 18 years up to 75 years old.
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
|Official title||Vitamin D Supplementation to Persistent Carriers of MRSA - A Double Blind, Randomised Controlled Trial|
|Principal investigator||Gudrun Lind, M.D PhD|
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