’D-STAPH’ Vitamin D supplementation to persistent carriers of MRSA – A double blind, randomised controlled trial - ’D-STAPH’

Karolinska University Hospital, Huddinge0 个研究点目标入组 300 人开始时间: 2014年3月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

Karolinska University Hospital, Huddinge