NCT03554668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

May 31, 2018

Last Update Submit

April 27, 2020

Conditions

InflammationMagnesium DeficiencyIron-deficiencyThiamine Deficiency

Outcome Measures

Primary Outcomes (3)

  • serum magnesium

    blood sample

    three months

  • thiamine

    blood sample

    three months

  • erythrocyte transketolase activity

    blood sample

    three months

Other Outcomes (1)

  • Iron receptor status

    three months

Study Arms (1)

1

Post total knee replacement patients

Diagnostic Test: Blood draw

Interventions

Blood drawDIAGNOSTIC_TEST

We take blood samples at pre-op and subsequent time points, up to three months post op.

1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective TKR

You may qualify if:

  • undergoing elective total knee replacement

You may not qualify if:

  • taking multivitamin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Related Publications (6)

  • Altura BM, Shah NC, Shah GJ, Zhang A, Li W, Zheng T, Perez-Albela JL, Altura BT. Short-term Mg deficiency upregulates protein kinase C isoforms in cardiovascular tissues and cells; relation to NF-kB, cytokines, ceramide salvage sphingolipid pathway and PKC-zeta: hypothesis and review. Int J Clin Exp Med. 2014 Jan 15;7(1):1-21. eCollection 2014.

    PMID: 24482684BACKGROUND

  • Wolf E, Utech M, Stehle P, Busing M, Stoffel-Wagner B, Ellinger S. Preoperative micronutrient status in morbidly obese patients before undergoing bariatric surgery: results of a cross-sectional study. Surg Obes Relat Dis. 2015 Sep-Oct;11(5):1157-63. doi: 10.1016/j.soard.2015.03.018. Epub 2015 Apr 2.

    PMID: 25980331BACKGROUND

  • Dibaba DT, Xun P, He K. Dietary magnesium intake is inversely associated with serum C-reactive protein levels: meta-analysis and systematic review. Eur J Clin Nutr. 2015 Mar;69(3):409. doi: 10.1038/ejcn.2014.275. Epub 2015 Jan 7. No abstract available.

    PMID: 25563736BACKGROUND

  • Crawford SO, Hoogeveen RC, Brancati FL, Astor BC, Ballantyne CM, Schmidt MI, Young JH. Association of blood lactate with type 2 diabetes: the Atherosclerosis Risk in Communities Carotid MRI Study. Int J Epidemiol. 2010 Dec;39(6):1647-55. doi: 10.1093/ije/dyq126. Epub 2010 Aug 25.

    PMID: 20797988BACKGROUND

  • Salih S, Sutton P. Obesity, knee osteoarthritis and knee arthroplasty: a review. BMC Sports Sci Med Rehabil. 2013 Dec 4;5(1):25. doi: 10.1186/2052-1847-5-25.

    PMID: 24304704BACKGROUND

  • Maguire D, Catchpole A, Sheerins O, Talwar D, Burns A, Blyth M, Shaw A, Jones B, Drury C, Harten J, Smith I, McMillan DC. The relation between acute changes in the systemic inflammatory response and circulating thiamine and magnesium concentrations after elective knee arthroplasty. Sci Rep. 2021 May 28;11(1):11271. doi: 10.1038/s41598-021-90591-y.

    PMID: 34050237DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

InflammationMagnesium DeficiencyAnemia, Iron-DeficiencyThiamine Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesVitamin B DeficiencyAvitaminosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Clinical Researcher

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 13, 2018

Study Start

January 15, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

We will publish anonymised results. No patient identifiable data will be shared.

Locations

GB(1)