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

Primary Purpose

Methicillin Resistant Staphylococcus Aureus, Vitamin D3 Deficiency

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Cholecalciferol

Placebo

About this trial

This is an interventional treatment trial for Methicillin Resistant Staphylococcus Aureus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.
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

Sites / Locations

Karolinska University Hospital
Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol

Sugarpill

Arm Description

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

150 patients with MRSA resistent Placebo daily 12 month

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Vitamin D levels in serum

Full Information

NCT ID

NCT02178488

First Posted

June 12, 2014

Last Updated

January 21, 2018

Sponsor

Peter Bergman

1. Study Identification

Unique Protocol Identification Number

NCT02178488

Brief Title

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

Acronym

D-STAPH

Official Title

Vitamin D Supplementation to Persistent Carriers of MRSA - A Double Blind, Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter Bergman

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Methicillin Resistant Staphylococcus Aureus, Vitamin D3 Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cholecalciferol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sugarpill

Arm Type

Placebo Comparator

Arm Description

150 patients with MRSA resistent Placebo daily 12 month

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Vigantol Oil (Germany) or Detremin (Sweden)

Intervention Description

Cholecalciferol 4000 IU/day for 12 months

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

MRSA

Description

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.

Time Frame

Baseline, 3, 6, 9 and 12 months

Secondary Outcome Measure Information:

Title

Vitamin D levels in serum

Time Frame

baseline, 3, 6, 9, 12, 18 and 24 months

Other Pre-specified Outcome Measures:

Title

Patterns of DNA methylation in immune cells

Description

Total DNA from whole blood will be isolated and analysed for methylation patterns using the bisulphite exchange method. Focus will be on methylation in genes related to vitamin D metabolism and immunity, including cytochrome p450 number 24 (CYP24), cytochrome p450 number 27 (CYP27) and cathelicidin antimicrobial peptide (CAMP) genes.

Time Frame

baseline, 3,6, 9, 12, 18 and 24 months

Title

Changes in microflora in the intestinal and nasal tracts

Time Frame

Baseline, 9, 12 and 24 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gudrun Lind, M.D PhD

Organizational Affiliation

Karolinska University Hospital, Solna. Department of Infectious Diseases

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter Bergman, M.D PhD

Organizational Affiliation

Karolinska University Hospital Huddinge, Department of Infectious Diseases

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska University Hospital

City

Stockholm

State/Province

Huddinge

ZIP/Postal Code

SE_ 141 86

Country

Sweden

Facility Name

Karolinska University Hospital

City

Stockholm

State/Province

Solna

ZIP/Postal Code

SE- 171 76

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23242238

Citation

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.

Results Reference

background

PubMed Identifier

20210515

Citation

Matheson 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.

Results Reference

background

PubMed Identifier

21263449

Citation

Hewison 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. Erratum In: Nat Rev Endocrinol. 2011 Aug;7(8):436.

Results Reference

background

PubMed Identifier

30157946

Citation

Bjorkhem-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.

Results Reference

derived

PubMed Identifier

29931657

Citation

Bjorkhem-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.

Results Reference

derived

Links:

URL

http://bmjopen.bmj.com/content/2/6/e001663.full.pdf+html

Description

A report on a previous study where vitamin D/Placebo was given to patients with frequent respiratory tract infections.

Learn more about this trial

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

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