This trial is active, not recruiting.

Conditions resistant staphylococcus aureus: [methicillin] or [multiple], cholecalciferol toxicity, staphylococcus aureus infections
Treatments cholecalciferol, placebo
Phase phase 2
Sponsor Peter Bergman
Start date December 2014
End date December 2016
Trial size 60 participants
Trial identifier NCT02178488, D-STAPH-EXT-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
150 patients with MRSA resistent Cholecalciferol 4000 international units (IU)/day for 12 month
cholecalciferol Vigantol Oil (Germany) or Detremin (Sweden)
Cholecalciferol 4000 IU/day for 12 months
(Placebo Comparator)
150 patients with MRSA resistent Placebo daily 12 month
Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months

Primary Outcomes

time frame: Baseline, 3, 6, 9 and 12 months

Secondary Outcomes

Vitamin D levels in serum
time frame: baseline, 3, 6, 9, 12, 18 and 24 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Vitamin D Supplementation to Persistent Carriers of MRSA - A Double Blind, Randomised Controlled Trial
Principal investigator Gudrun Lind, M.D PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.