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Systemic Inflammatory Response: Thiamine and Magnesium Status (Sir TaM Study) (SirTaM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03554668
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Dr. Donogh Maguire, Glasgow Royal Infirmary

Brief Summary:

We wish to determine to what extent magnesium, thiamine and transketolase activity are affected by the Systemic Inflammatory Response (SIR). The knee arthroplasty model affords the ideal study design, as surgery generates an inflammatory response.

Blood samples are drawn preoperatively and for up to four days post operatively, and again at three months post-operation.

Condition or disease Intervention/treatment
Inflammation Magnesium Deficiency Iron-deficiency Thiamine Deficiency Diagnostic Test: Blood draw

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relation Between Acute Changes in the Systemic Inflammatory Response, Thiamine and Magnesium Concentrations and Transketolase Activity After Elective Knee Arthroplasty.
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : June 1, 2019

Group/Cohort Intervention/treatment
Post total knee replacement patients
Diagnostic Test: Blood draw
We take blood samples at pre-op and subsequent time points, up to three months post op.

Primary Outcome Measures :
  1. serum magnesium [ Time Frame: three months ]
    blood sample

  2. thiamine [ Time Frame: three months ]
    blood sample

  3. erythrocyte transketolase activity [ Time Frame: three months ]
    blood sample

Other Outcome Measures:
  1. Iron receptor status [ Time Frame: three months ]
    blood sample

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective TKR

Inclusion Criteria:

  • undergoing elective total knee replacement

Exclusion Criteria:

  • taking multivitamin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03554668

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United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G4 0SF
Contact: Donogh Maguire, MB BCh    0141 2115166   
Contact: Blyth Mark, Mb BCh    0141 2114000   
Sponsors and Collaborators
Glasgow Royal Infirmary
NHS Greater Glasgow and Clyde

Additional Information:
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Responsible Party: Dr. Donogh Maguire, Emergency Medicine Clinical Researcher, Glasgow Royal Infirmary Identifier: NCT03554668     History of Changes
Other Study ID Numbers: REC reference 17/EE/0270
225557 ( Registry Identifier: IRAS )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will publish anonymised results. No patient identifiable data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Thiamine Deficiency
Magnesium Deficiency
Pathologic Processes
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamin B Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs