Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis

NCT06267053 | Completed

• 1 other identifier: 2023/469
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the relationship between folic acid, vitamin B12 and 25-OH vitamin D levels and radiographic staging in patients diagnosed with primary gonarthrosis.

Conditions

Knee Osteoarthritis

Keywords

Vitamin B12; Folate; Vitamin D; Gonarthrosis

Outcome Measures

Primary Outcomes (3)

• 25-OH Vitamin D (25(OH)D) and Kellgren Lawrence Grade

  One way ANOVA was used to determine the relationship between 25(OH)D and radiographical grade.

  Baseline

• Vitamin B12 and Kellgren Lawrence Grade

  Kruskal Wallis H Test was used to determine the relationship between Vitamin B12 and radiographical grade.

  Baseline

• Folic acid and Kellgren Lawrence Grade

  Kruskal Wallis H Test was used to determine the relationship between Folic acid and radiographical grade.

  Baseline

Study Arms (1)

Kellgren Lawrence Grade

Patients are divided into four groups based on Kellgren lawrence stage

Diagnostic Test: Direct digital radiography; Diagnostic Test: 25-OH Vitamin D; Diagnostic Test: Vitamin B12; Diagnostic Test: Folic acid

Interventions

Direct digital radiography DIAGNOSTIC_TEST

All the participants had anterior posterior and lateral knee xray taken within 3 months of diagnosis

Kellgren Lawrence Grade

25-OH Vitamin D DIAGNOSTIC_TEST

All the participants had serum 25-OH Vitamin D levels measured from venous blood within 30 days of diagnosis

Kellgren Lawrence Grade

Vitamin B12 DIAGNOSTIC_TEST

All the participants had serum Vitamin B12 levels measured from venous blood within 30 days of diagnosis

Kellgren Lawrence Grade

Folic acid DIAGNOSTIC_TEST

All the participants had serum folic acid levels measured from venous blood within 30 days of diagnosis

Kellgren Lawrence Grade

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patiens over 50 years old who presented to Bakirkoy Dr. Sadi Konuk Training and Reserach hospital's outpatient clinic of Physical Medicine and Rehabilitation with knee pain and diagnosed with gonarthrosis according to American College of Rheumatology (ACR) criteria

You may qualify if:

• Adults (Age: 50-80) with primary gonarthrosis
• Anterior-posterior and lateral knee direct digital radiography within 3 months of diagnosis
• Vitamin B12, folic acid and 25-OH Vitamin D within 1 months of diagnosis

You may not qualify if:

• History of inflammatory or rheumatologic disease
• History of lower extremity surgery
• Pregnancy
• Active malignancy
• Severe mental disability

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (22)

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• Gao XR, Chen YS, Deng W. The effect of vitamin D supplementation on knee osteoarthritis: A meta-analysis of randomized controlled trials. Int J Surg. 2017 Oct;46:14-20. doi: 10.1016/j.ijsu.2017.08.010. Epub 2017 Aug 7.

  PMID: 28797917 BACKGROUND

• Perry TA, Parkes MJ, Hodgson R, Felson DT, O'Neill TW, Arden NK. Effect of Vitamin D supplementation on synovial tissue volume and subchondral bone marrow lesion volume in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2019 Feb 14;20(1):76. doi: 10.1186/s12891-019-2424-4.

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• Namutebi F, Kayima J, Kaddumukasa M. Vitamin D and its association with symptom severity in knee osteoarthritis: a cross sectional study at a national referral hospital in Uganda. BMC Rheumatol. 2021 Dec 27;5(1):56. doi: 10.1186/s41927-021-00228-w.

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• Askari A, Ariya M, Davoodi SH, Shahraki HR, Ehrampoosh E, Homayounfar R. Vitamin K and D Status in Patients with Knee Osteoarthritis: An Analytical Cross-sectional Study. Mediterr J Rheumatol. 2021 Dec 27;32(4):350-357. doi: 10.31138/mjr.32.4.350. eCollection 2021 Dec.

  PMID: 35128328 BACKGROUND

• Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.

  PMID: 3741515 BACKGROUND

• KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.

  PMID: 13498604 BACKGROUND

• Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.

  PMID: 21646368 BACKGROUND

• Vargas-Uricoechea H, Nogueira JP, Pinzon-Fernandez MV, Agredo-Delgado V, Vargas-Sierra HD. Population Status of Vitamin B12 Values in the General Population and in Individuals with Type 2 Diabetes, in Southwestern Colombia. Nutrients. 2023 May 18;15(10):2357. doi: 10.3390/nu15102357.

  PMID: 37242240 BACKGROUND

• Singh G, Hamdan H, Singh V. Clinical utility of serum folate measurement in tertiary care patients: Argument for revising reference range for serum folate from 3.0 ng/mL to 13.0 ng/mL. Pract Lab Med. 2015 Mar 26;1:35-41. doi: 10.1016/j.plabm.2015.03.005. eCollection 2015 Apr 1.

  PMID: 28932797 BACKGROUND

• Agostini D, Donati Zeppa S. Vitamin D, Diet and Musculoskeletal Health. Nutrients. 2023 Jun 27;15(13):2902. doi: 10.3390/nu15132902.

  PMID: 37447228 BACKGROUND

• Malas FU, Kara M, Kaymak B, Akinci A, Ozcakar L. Ultrasonographic evaluation in symptomatic knee osteoarthritis: clinical and radiological correlation. Int J Rheum Dis. 2014 Jun;17(5):536-40. doi: 10.1111/1756-185X.12190. Epub 2013 Oct 29.

  PMID: 24618242 BACKGROUND

• Malas FU, Kara M, Aktekin L, Ersoz M, Ozcakar L. Does vitamin D affect femoral cartilage thickness? An ultrasonographic study. Clin Rheumatol. 2014 Sep;33(9):1331-4. doi: 10.1007/s10067-013-2432-y. Epub 2013 Nov 13.

  PMID: 24221506 BACKGROUND

• Edd SN, Omoumi P, Jolles BM, Favre J. Longitudinal Femoral Cartilage T2 Relaxation Time and Thickness Changes with Fast Sequential Radiographic Progression of Medial Knee Osteoarthritis-Data from the Osteoarthritis Initiative (OAI). J Clin Med. 2021 Mar 21;10(6):1294. doi: 10.3390/jcm10061294.

  PMID: 33801000 BACKGROUND

• Mermerci Baskan B, Yurdakul FG, Aydin E, Sivas F, Bodur H. Effect of vitamin D levels on radiographic knee osteoarthritis and functional status. Turk J Phys Med Rehabil. 2017 Apr 4;64(1):1-7. doi: 10.5606/tftrd.2018.986. eCollection 2018 Mar.

  PMID: 31453483 BACKGROUND

• Bevilacqua G, Laskou F, Clynes MA, Jameson KA, Boucher BJ, Noonan K, Cooper C, Dennison EM. Determinants of circulating 25-hydroxyvitamin D concentration and its association with musculoskeletal health in midlife: Findings from the Hertfordshire Cohort Study. Metabol Open. 2021 Oct 26;12:100143. doi: 10.1016/j.metop.2021.100143. eCollection 2021 Dec.

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• Elbashir M, Shubayr N, Alghathami A, Ali S, Alyami A, Alumairi N, Abdelrazig A, Omer AM, Elbasheer O. Investigation of Vitamin D Status, Age, and Body Mass Index as Determinants of Knee Osteoarthritis Severity Using the Kellgren-Lawrence Grading System in a Saudi Arabian Cohort: A Cross-Sectional Study. Cureus. 2023 Oct 23;15(10):e47523. doi: 10.7759/cureus.47523. eCollection 2023 Oct.

  PMID: 38021605 BACKGROUND

• Blom AB, van Lent PL, Holthuysen AE, van der Kraan PM, Roth J, van Rooijen N, van den Berg WB. Synovial lining macrophages mediate osteophyte formation during experimental osteoarthritis. Osteoarthritis Cartilage. 2004 Aug;12(8):627-35. doi: 10.1016/j.joca.2004.03.003.

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• de Visser HM, Korthagen NM, Muller C, Ramakers RM, Krijger GC, Lafeber FPJG, Beekman FJ, Mastbergen SC, Weinans H. Imaging of Folate Receptor Expressing Macrophages in the Rat Groove Model of Osteoarthritis: Using a New DOTA-Folate Conjugate. Cartilage. 2018 Apr;9(2):183-191. doi: 10.1177/1947603517738073. Epub 2017 Nov 3.

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• Xu H, Shin MH, Kang JH, Choi SE, Park DJ, Kweon SS, Lee YH, Kim HY, Lee JK, Lee SS. Folate deficiency is associated with increased radiographic severity of osteoarthritis in knee joints but not in hand joints. Clin Exp Rheumatol. 2023 May;41(5):1149-1154. doi: 10.55563/clinexprheumatol/69k9xr. Epub 2022 Oct 12.

  PMID: 36226605 BACKGROUND

• Hong H, Chen L, Zhong Y, Yang Z, Li W, Song C, Leng H. Associations of Homocysteine, Folate, and Vitamin B12 with Osteoarthritis: A Mendelian Randomization Study. Nutrients. 2023 Mar 28;15(7):1636. doi: 10.3390/nu15071636.

  PMID: 37049476 BACKGROUND

• Thomson A, Hilkens CMU. Synovial Macrophages in Osteoarthritis: The Key to Understanding Pathogenesis? Front Immunol. 2021 Jun 15;12:678757. doi: 10.3389/fimmu.2021.678757. eCollection 2021.

  PMID: 34211470 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood was taken to serum-separating tube from the patients.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Radiography, Dental, Digital

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiographic Image Enhancement; Image Enhancement; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Radiography, Dental; Diagnosis, Oral; Dentistry

Study Officials

• Filiz YILDIZ AYDIN

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Sibel CAGLAR

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  STUDY CHAIR

• Arda Can KASAP

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: December 1, 2023
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)