E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To test the hypothesis that vitamin D treatment during 1 year can reduce the number of patients positive for MRSA |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the number of MRSA-negative patients |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 12 months intervention |
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E.5.2 | 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.
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 31 |