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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Methicillin Resistant Staphylococcus Aureus Vitamin D3 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cholecalciferol

150 patients with MRSA resistent Cholecalciferol 4000 international units (IU)/day for 12 month

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

Cholecalciferol 4000 IU/day for 12 months

Sugarpill

150 patients with MRSA resistent Placebo daily 12 month

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months

Interventions

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Cholecalciferol

Cholecalciferol 4000 IU/day for 12 months

Intervention Type DRUG

Placebo

Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months

Intervention Type OTHER

Other Intervention Names

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Vigantol Oil (Germany) or Detremin (Sweden)

Eligibility Criteria

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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 pregnancy test (U-hcg) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral).

Exclusion Criteria

1. Should not be on vitamin D supplementation at least 6 months prior to inclusion.
2. Serum level of 25-hydroxy 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 sarcoidosis
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 thiazides
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 cholecalciferol and/or any of the excipients
17. Other criteria that could jeopardize the study or its intention as judged by the investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No