Vitamin D supplementation to persistent carriers of MRSA

Phase 1

Conditions: Persistent MRSA carriers
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2014-000149-53-SE

Lead Sponsor: Karolinska University Hospital, Huddinge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures