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Trial record 13 of 22 for:    "Beriberi"

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

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ClinicalTrials.gov Identifier: NCT03554668
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
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
1
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
Blood


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03554668


Locations
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United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G4 0SF
Contact: Donogh Maguire, MB BCh    0141 2115166    Donogh.Maguire@gla.ac.uk   
Contact: Blyth Mark, Mb BCh    0141 2114000    Mark.Blyth@ggc.scot.nhs.uk   
Sponsors and Collaborators
Glasgow Royal Infirmary
NHS Greater Glasgow and Clyde

Additional Information:
Publications:
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Responsible Party: Dr. Donogh Maguire, Emergency Medicine Clinical Researcher, Glasgow Royal Infirmary
ClinicalTrials.gov 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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Thiamine Deficiency
Beriberi
Inflammation
Anemia, Iron-Deficiency
Magnesium Deficiency
Pathologic Processes
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs