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

NCT02178488 | Completed Phase 2

• 1 other identifier: D-STAPH-EXT-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Methicillin Resistant Staphylococcus Aureus; Vitamin D3 Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vitamin D levels in serum

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

Other Outcomes (2)

• Patterns of DNA methylation in immune cells

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

• Changes in microflora in the intestinal and nasal tracts

  Baseline, 9, 12 and 24 month

Study Arms (2)

Cholecalciferol

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Sugarpill

PLACEBO COMPARATOR

150 patients with MRSA resistent Placebo daily 12 month

Other: Placebo

Interventions

Cholecalciferol DRUG

Cholecalciferol 4000 IU/day for 12 months

Also known as: Vigantol Oil (Germany) or Detremin (Sweden)

Cholecalciferol

Placebo OTHER

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

Sugarpill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Serum level of 25-hydroxy vitamin D3 \>75 nmol/L
• 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
• 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

Sponsors & Collaborators

• Peter Bergman: lead

Study Sites (2)

Karolinska University Hospital

Stockholm, Huddinge, SE_ 141 86, Sweden

Location

Karolinska University Hospital

Stockholm, Solna, SE- 171 76, Sweden

Location

Related Publications (5)

• 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.

  PMID: 23242238 BACKGROUND

• 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.

  PMID: 20210515 BACKGROUND

• 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.

  PMID: 21263449 BACKGROUND

• 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.

  PMID: 30157946 DERIVED

• 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.

  PMID: 29931657 DERIVED

Related Links

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

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Gudrun Lind, M.D PhD

  Karolinska University Hospital, Solna. Department of Infectious Diseases

  PRINCIPAL INVESTIGATOR

• Peter Bergman, M.D PhD

  Karolinska University Hospital Huddinge, Department of Infectious Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 30, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

SE (2)