NCT02336932

Brief Summary

The purpose of this study is to describe changes in vitamin D parameters before, during and after a well-defined elective surgical trauma (knee arthroplasty) and to compare these changes to other steroid hormones (testosterone and oestrogens). The hypothesis is that profound changes in free and total vitamin D will occur as a result of changes between intravascular vs extravascular protein compartments during surgical trauma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

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

First Submitted

Initial submission to the registry

November 13, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

November 13, 2014

Last Update Submit

March 25, 2019

Conditions

ArthrosisSurgery

Keywords

vitamin dfree hormonesurgical stress

Outcome Measures

Primary Outcomes (1)

  • • Changes in total and calculated free 25-hydroxyvitamin D and 1,25dihydroxyvitamin D postoperatively.

    Changes in serum concentration of total and free vitamin D metabolites

    2, 6, 24,48 hours and 3 weeks postoperatively.

Secondary Outcomes (5)

  • changes in serum concentrations of total calcium, albumin corrected calcium, phosphate, alkaline phosphatase and PTH

    2, 6, 24,48 hours and 3 weeks postoperatively.

  • •Dependence of sex in the changes in total and calculated free 25-hydroxyvitamin D and 1,25dihydroxyvitamin D, calcium, AP and PTH

    2, 6, 24,48 hours and 3 weeks postoperatively.

  • • Changes in total and calculated free 25-hydroxyvitamin D and 1,25dihydroxyvitamin D dependent on preoperative vitamin D status

    2, 6, 24,48 hours and 3 weeks postoperatively.

  • • Secondary changes in serum of FGF23, Klotho, RANKL, OPG, osteocalcin, osteopontin, Sclerostin and IGF-1

    2, 6, 24,48 hours and 3 weeks postoperatively.

  • • Temporal changes in serum level of vitamin D binding protein, albumin and sex hormone binding globulin.

    2, 6, 24,48 hours and 3 weeks postoperatively.

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20 otherwise healthy patients (10 males and 10 females) age 50-75 years undergoing elective total knee arthroplasty in Department of Orthopaedic Surgery, Hvidovre Hospital. All patients undergo standard anaesthesia and analgesic treatment in a fast-track set-up with discharge not earlier than 48-hours postoperatively.

You may qualify if:

  • healthy patients (10 males and 10 females)
  • age 50-75 years
  • undergoing elective total knee arthroplasty at Department of Orthopaedic Surgery, Hvidovre Hospital

You may not qualify if:

  • intake of high dose vitamin D (above 10 microgram daily),
  • serious co-morbidities such as previous myocardial infarct, heart, kidney or liver failure, severe rheumatological disorders, existing endocrine disorders in thyroid, pancreas, testis, adrenal,
  • Disorders related to calcium metabolism, hypercalcemia,
  • Granulomatous disease such as Wegener, tuberculosis, etc,
  • Previous or present malignant disease, inflammatory bowel disease
  • Current use of medication that influence protein binding and renal excretion (allopurinol, diuretics, hormones. immunosuppressive therapy)
  • Elevated serum creatinine
  • Non-european ethnicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet/Hvidovre hospital

Copenhagen, 2100, Denmark

Location

Related Publications (11)

  • Blomberg Jensen M. Vitamin D and male reproduction. Nat Rev Endocrinol. 2014 Mar;10(3):175-86. doi: 10.1038/nrendo.2013.262. Epub 2014 Jan 14.

    PMID: 24419359BACKGROUND

  • Prosser DE, Jones G. Enzymes involved in the activation and inactivation of vitamin D. Trends Biochem Sci. 2004 Dec;29(12):664-73. doi: 10.1016/j.tibs.2004.10.005.

    PMID: 15544953BACKGROUND

  • Nykjaer A, Dragun D, Walther D, Vorum H, Jacobsen C, Herz J, Melsen F, Christensen EI, Willnow TE. An endocytic pathway essential for renal uptake and activation of the steroid 25-(OH) vitamin D3. Cell. 1999 Feb 19;96(4):507-15. doi: 10.1016/s0092-8674(00)80655-8.

    PMID: 10052453BACKGROUND

  • Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.

    PMID: 22066560BACKGROUND

  • Rem J, Nielsen OS, Brandt MR, Kehlet H. Release mechanisms of postoperative changes in various acute phase proteins and immunoglobulins. Acta Chir Scand Suppl. 1980;502:51-6.

    PMID: 6941601BACKGROUND

  • Brandt MR, Kehlet H, Skovsted L, Hansen JM. Rapid decrease in plasma-triiodothyronine during surgery and epidural analgesia independent of afferent neurogenic stimuli and of cortisol. Lancet. 1976 Dec 18;2(7999):1333-6. doi: 10.1016/s0140-6736(76)91977-2.

    PMID: 63806BACKGROUND

  • Turan A, Hesler BD, You J, Saager L, Grady M, Komatsu R, Kurz A, Sessler DI. The association of serum vitamin D concentration with serious complications after noncardiac surgery. Anesth Analg. 2014 Sep;119(3):603-612. doi: 10.1213/ANE.0000000000000096.

    PMID: 25121616BACKGROUND

  • Zaloga GP, Butterworth JF 4th. Hypovitaminosis D in hospitalized patients: a marker of frailty or a disease requiring treatment? Anesth Analg. 2014 Sep;119(3):613-618. doi: 10.1213/ANE.0000000000000368. No abstract available.

    PMID: 25136999BACKGROUND

  • Kehlet H, Madsen SN, Binder C. Cortisol and cortisone acetate in parenteral glucocorticoid therapy? Acta Med Scand. 1974 May;195(5):421-3. doi: 10.1111/j.0954-6820.1974.tb08163.x. No abstract available.

    PMID: 4830060BACKGROUND

  • Reid D, Toole BJ, Knox S, Talwar D, Harten J, O'Reilly DS, Blackwell S, Kinsella J, McMillan DC, Wallace AM. The relation between acute changes in the systemic inflammatory response and plasma 25-hydroxyvitamin D concentrations after elective knee arthroplasty. Am J Clin Nutr. 2011 May;93(5):1006-11. doi: 10.3945/ajcn.110.008490. Epub 2011 Mar 16.

    PMID: 21411617BACKGROUND

  • Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231.

    PMID: 20926724BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • martin B Jensen, MD, DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc

Study Record Dates

First Submitted

November 13, 2014

First Posted

January 13, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

July 1, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

DK(1)