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Completed

NCT Number: NCT02178488

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

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.

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Key information

Conditions

Methicillin Resistant Staphylococcus Aureus Vitamin D3 Deficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska University Hospital, Stockholm, Huddinge, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Cholecalciferol 4000 IU/day for 12 months

Other names: Vigantol Oil (Germany) or Detremin (Sweden)

Placebo

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Vitamin D levels in serum

    Time frame: baseline, 3, 6, 9, 12, 18 and 24 months

Other outcomes

  1. Patterns of DNA methylation in immune cells

    Time frame: baseline, 3,6, 9, 12, 18 and 24 months

    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.

  2. Changes in microflora in the intestinal and nasal tracts

    Time frame: Baseline, 9, 12 and 24 month

Sponsors and collaborators

Lead sponsor

Peter Bergman

Other

Registry information

Official study title

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

Acronym: D-STAPH

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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