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

Vitamin D3 Deficiency Clinical Trial

— D-STAPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178488
• Other study ID #: D-STAPH-EXT-01
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2014
• Last updated: January 21, 2018
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Methicillin Resistant Staphylococcus Aureus
• Staphylococcal Infections
• Vitamin D3 Deficiency

Intervention

Drug:
• Cholecalciferol
Cholecalciferol 4000 IU/day for 12 months

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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm	Huddinge
Sweden	Karolinska University Hospital	Stockholm	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Peter Bergman

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Bergman P, Norlin AC, Hansen S, Rekha RS, Agerberth B, Björkhem-Bergman L, Ekström 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). pii: e001663. doi: 10.1136/bmjopen-2012-001663. Print 2012. — View 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. Review. Erratum in: Nat Rev Endocrinol. 2011 Aug;7(8):436. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patterns of DNA methylation in immune cells	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.	baseline, 3,6, 9, 12, 18 and 24 months
Other	Changes in microflora in the intestinal and nasal tracts		Baseline, 9, 12 and 24 month
Primary	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.	Baseline, 3, 6, 9 and 12 months
Secondary	Vitamin D levels in serum		baseline, 3, 6, 9, 12, 18 and 24 months

External Links

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