Efficacy Study of Vitamin D Supplementation to Meticillin Resistant Staphylococcus Aureus (MRSA) Carriers

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D Supplementation to Persistent Carriers of MRSA - A Double Blind, Randomised Controlled Trial

Conditions
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Methicillin Resistant Staphylococcus Aureus, Vitamin D3 Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Men and women aged ≥18-75 Signed 'informed consent' Negative pregnancy test (U-hcg) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral). Exclusion Criteria: Should not be on vitamin D supplementation at least 6 months prior to inclusion. Serum level of 25-hydroxy vitamin D3 >75 nmol/L Ongoing and continuous antibiotic treatment. The patient should be off antibiotics at least 30 days prior to inclusion Known sarcoidosis Primary or secondary hyperparathyroidism Kidney failure as defined as a normal age-adjusted creatinin. Long term systemic treatment with corticosteroids or other immunosuppressive medication Taking thiazides Hypercalcaemia (verified by a laboratory result younger than 2 month) Ongoing malignancy disorder If plans to leave the Stockholm county within 12 months of inclusion History of kidney stones Pregnancy (ongoing or planned) Breastfeeding women Taking part of another clinical study involving drugs Hypersensitivity to cholecalciferol and/or any of the excipients Other criteria that could jeopardize the study or its intention as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecalciferol<br>150 patients with MRSA resistent Cholecalciferol 4000 international units (IU)/day for 12 month | Drug: Cholecalciferol<br>* Cholecalciferol 4000 IU/day for 12 months<br>* Other names: Vigantol Oil (Germany) or Detremin (Sweden);|
| Placebo Comparator: Sugarpill<br>150 patients with MRSA resistent Placebo daily 12 month | Other: Placebo<br>* Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels in serum |  | baseline, 3, 6, 9, 12, 18 and 24 months |