Methicillin Resistant Staphylococcus AureusPhase 2D-STAPHNCT02178488
Efficacy Study of Vitamin D Supplementation to Meticillin Resistant Staphylococcus Aureus (MRSA) Carriers
A Phase 2 study testing Cholecalciferol in people with Methicillin Resistant Staphylococcus Aureus and Vitamin D3 Deficiency, run by Peter Bergman at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Methicillin Resistant Staphylococcus Aureus, Vitamin D3 Deficiency
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSweden
- Study dates
- Dec 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Men and women aged ≥18-75
- Signed 'informed consent'
- Negative pregnancy test (U-hcg) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral).
Who cannot join
- Should not be on vitamin D supplementation at least 6 months prior to inclusion.
- Serum level of 25-hydroxy vitamin D3 >75 nmol/L
- Ongoing and continuous antibiotic treatment. The patient should be off antibiotics at least 30 days prior to inclusion
- Known sarcoidosis
- Primary or secondary hyperparathyroidism
- Kidney failure as defined as a normal age-adjusted creatinin.
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- Long term systemic treatment with corticosteroids or other immunosuppressive medication
- Taking thiazides
- Hypercalcaemia (verified by a laboratory result younger than 2 month)
- Ongoing malignancy disorder
- If plans to leave the Stockholm county within 12 months of inclusion
- History of kidney stones
- Pregnancy (ongoing or planned)
- Breastfeeding women
- Taking part of another clinical study involving drugs
- Hypersensitivity to cholecalciferol and/or any of the excipients
- Other criteria that could jeopardize the study or its intention as judged by the investigator
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska University Hospital
Stockholm, Huddinge, SE_ 141 86
Karolinska University Hospital
Stockholm, Solna, SE- 171 76
About this study
Official title: Vitamin D Supplementation to Persistent Carriers of MRSA - A Double Blind, Randomised Controlled Trial
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.
- Being tested
- Cholecalciferol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vigantol Oil (Germany) or Detremin (Sweden)
Cholecalciferol 4000 IU/day for 12 months
PlaceboOther
Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Active comparator | 150 patients with MRSA resistent Cholecalciferol 4000 international units (IU)/day for 12 month Receives: Drug: Cholecalciferol |
| Sugarpill | Placebo comparator | 150 patients with MRSA resistent Placebo daily 12 month Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRSA
The primary endpoint is the decline of MRSA-positive patients during a 12-month period in the treatment groups (vitamin D/Placebo) based on 5 measurements with 3 months interval.
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (1)
Vitamin D levels in serum
Measured: baseline, 3, 6, 9, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Methicillin Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Bergman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Bergman, Karolinska University Hospital
- Investigators
- Gudrun Lind, M.D PhD, Principal investigator, Karolinska University Hospital, Solna. Department of Infectious DiseasesPeter Bergman, M.D PhD, Principal investigator, Karolinska University Hospital Huddinge, Department of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178488
- Sponsor's protocol ID
- D-STAPH-EXT-01
- Acronym
- D-STAPH
- Status last verified
- Jan 2018
- First submitted
- 12 Jun 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bergman P, Norlin AC, Hansen S, Rekha RS, Agerberth B, Bjorkhem-Bergman L, Ekstrom L, Lindh JD, Andersson J. Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study. BMJ Open. 2012 Dec 13;2(6):e001663. doi: 10.1136/bmjopen-2012-001663. Print 2012.
PubMed 23242238Matheson EM, Mainous AG 3rd, Hueston WJ, Diaz VA, Everett CJ. Vitamin D and methicillin-resistant Staphylococcus aureus nasal carriage. Scand J Infect Dis. 2010 Jul;42(6-7):455-60. doi: 10.3109/00365541003602049.
PubMed 20210515Hewison M. Antibacterial effects of vitamin D. Nat Rev Endocrinol. 2011 Jun;7(6):337-45. doi: 10.1038/nrendo.2010.226. Epub 2011 Jan 25.
PubMed 21263449Bjorkhem-Bergman L, Torefalk E, Ekstrom L, Bergman P. Vitamin D binding protein is not affected by high-dose vitamin D supplementation: a post hoc analysis of a randomised, placebo-controlled study. BMC Res Notes. 2018 Aug 29;11(1):619. doi: 10.1186/s13104-018-3725-7.
PubMed 30157946Bjorkhem-Bergman L, Missailidis C, Karlsson-Valik J, Tammelin A, Ekstrom L, Bottai M, Hammar U, Lindh G, Bergman P. Vitamin D supplementation to persistent carriers of MRSA-a randomized and placebo-controlled clinical trial. Eur J Clin Microbiol Infect Dis. 2018 Sep;37(9):1735-1744. doi: 10.1007/s10096-018-3306-7. Epub 2018 Jun 21.
PubMed 29931657
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation to Persistent Carriers of MRSA - A Double Blind, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02178488
- Acronym / sponsor ID
- D-STAPH / D-STAPH-EXT-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peter BergmanUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Active comparator | Drug: Cholecalciferol150 patients with MRSA resistent Cholecalciferol 4000 international units (IU)/day for 12 month |
| Sugarpill | Placebo comparator | Other: Placebo150 patients with MRSA resistent Placebo daily 12 month |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Men and women aged ≥18-75
- Signed 'informed consent'
- Negative pregnancy test (U-hcg) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral).
Key exclusion criteria (17 listed)
- Should not be on vitamin D supplementation at least 6 months prior to inclusion.
- Serum level of 25-hydroxy vitamin D3 >75 nmol/L
- Ongoing and continuous antibiotic treatment. The patient should be off antibiotics at least 30 days prior to inclusion
- Known sarcoidosis
- Primary or secondary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: Vigantol Oil (Germany) or Detremin (Sweden)Cholecalciferol 4000 IU/day for 12 months | Drug | Cholecalciferol |
| PlaceboPlacebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months | Other | Sugarpill |
Primary outcome
MRSA
Time frame: Baseline, 3, 6, 9 and 12 months
The primary endpoint is the decline of MRSA-positive patients during a 12-month period in the treatment groups (vitamin D/Placebo) based on 5 measurements with 3 months interval.
1 secondary outcome
Vitamin D levels in serum
Time frame: baseline, 3, 6, 9, 12, 18 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 23242238Bergman P, Norlin AC, Hansen S, Rekha RS, Agerberth B, Bjorkhem-Bergman L, Ekstrom L, Lindh JD, Andersson J. Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study. BMJ Open. 2012 Dec 13;2(6):e001663. doi: 10.1136/bmjopen-2012-001663. Print 2012.
- Background: PubMed 20210515Matheson EM, Mainous AG 3rd, Hueston WJ, Diaz VA, Everett CJ. Vitamin D and methicillin-resistant Staphylococcus aureus nasal carriage. Scand J Infect Dis. 2010 Jul;42(6-7):455-60. doi: 10.3109/00365541003602049.
- Background: PubMed 21263449Hewison M. Antibacterial effects of vitamin D. Nat Rev Endocrinol. 2011 Jun;7(6):337-45. doi: 10.1038/nrendo.2010.226. Epub 2011 Jan 25.
- Derived from this study: PubMed 30157946Bjorkhem-Bergman L, Torefalk E, Ekstrom L, Bergman P. Vitamin D binding protein is not affected by high-dose vitamin D supplementation: a post hoc analysis of a randomised, placebo-controlled study. BMC Res Notes. 2018 Aug 29;11(1):619. doi: 10.1186/s13104-018-3725-7.
- Derived from this study: PubMed 29931657Bjorkhem-Bergman L, Missailidis C, Karlsson-Valik J, Tammelin A, Ekstrom L, Bottai M, Hammar U, Lindh G, Bergman P. Vitamin D supplementation to persistent carriers of MRSA-a randomized and placebo-controlled clinical trial. Eur J Clin Microbiol Infect Dis. 2018 Sep;37(9):1735-1744. doi: 10.1007/s10096-018-3306-7. Epub 2018 Jun 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gudrun Lind, M.D PhD principal investigator
Karolinska University Hospital, Solna. Department of Infectious Diseases
Peter Bergman, M.D PhD principal investigator
Karolinska University Hospital Huddinge, Department of Infectious Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Methicillin Resistant Staphylococcus Aureus and Vitamin D3 Deficiency, run by Peter Bergman at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRSA (time frame: Baseline, 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178488, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.