Persistent MRSA carriers
Conditions
Interventions
Trade Name: Detremin
Pharmaceutical Form: Oral drops
INN or Proposed INN: cholecalciferol
Current Sponsor code: 077799
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (OILY FORM)
Concentration uni
Sponsors
Karolinska University Hospital, Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
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 pregnacytest (U-HCG) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1.Should not be on vitamin D supplementation at least 6 months prior to inclusion. 2.Serum level of 25-OH 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 sarkoidosis 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 tiazides 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 cholecalicalciferol and/or any other 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 |
|---|---|
| Main Objective: To test the hypothesis that vitamin D treatment during 1 year can reduce the number of patients positive for MRSA;Secondary Objective: To assess vitamin D levels in serum and to assess how vitamin D affect DNA-methylation in whole blood as well as impact on the composition on the normal microflora.;Primary end point(s): The primary endpoint is the number of MRSA-negative patients ;Timepoint(s) of evaluation of this end point: After 12 months intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: 1.Levels of 25-OH vitamin D3 in serum. The analysis will be carried out by the routine clinical chemistry laboratory, Karolinska University Laboratory2.DNA-methylation patterns in whole-blood. Total DNA from whole blood will be isolated and analysed for methylation patterns using the bisulphite exchange method (0, 3, 6, 9, 12, 18 and 24 months). 3.The composition of the bacterial microflora in the intestinal and nasal tracts. Samples for analyses of the microflora will be taken from the nasal tract and from faeces at time points (0, 12 and 24 months). This material will be subjected to metagenomic analyses (shotgun sequencing and 16S RNA based sequencing) in collaboration with SciLifeLab, KI, Stockholm. ;Timepoint(s) of evaluation of this end point: 1. Levels of 25- OH vitamin D 3 in serum will be analyzed: 0, 3, 6, 9, 12, 18 and 24 months. 2.DNA-methylation patterns in whole-blood. at 0, 3, 6, 9, 12, 18 and 24 months. 3.The composition of the bacterial microflora in the intestinal and nasal tracts. Samples for analyses of the microflora will be taken at time points 0, 12 and 24 months. | — |
Countries
Sweden
Contacts
Public ContactClinical Research Manager
Karolinska Trial Alliance
Outcome results
None listed