Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Investigation of the Relationship Between Vitamin B12, Folic Acid and 25 OH D Levels and Radiologic Stage in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06267053
• Other study ID #: 2023/469
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: January 20, 2024

Study information

• Verified date: February 2024
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

While in the past osteoarthritis (OA) was believed to be a degenerative disease of cartilage alone, recently, many factors such as trauma, mechanical strain, inflammation, biochemical reactions, and metabolic irregularities have been shown to be involved in its etiology. Until now there have been many studies done to investigate the relationship between serum 25-OH Vitamin D (25(OH)D) levels and knee OA however the relationship between folic acid, vitamin B12 and knee OA has been rarely studied. Therefore, the aim of this study is to investigate the relationship between folic acid, vitamin B12 and 25(OH)D levels and radiographic staging in patients diagnosed with primary gonarthrosis.

The files of patients who presented to Sadi Konuk Training and Research Hospital's outpatient clinic of Physical Medicine and Rehabilitation with knee pain between June and December 2023 and were diagnosed with gonarthrosis according to the American College of Rheumatology (ACR) classification criteria were retrospectively reviewed.

Either one way ANOVA or Kruskal Wallis H test was used to compare means determined based on the result of the Shapiro Wilk test. Bonferroni PostHoc was used to compare between groups. The statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) version 21 (New York, USA) with significance set at p < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of inflammatory or rheumatologic disease

• History of lower extremity surgery

• Pregnancy

• Active malignancy

• Severe mental disability

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Diagnostic Test:
• Direct digital radiography
All the participants had anterior posterior and lateral knee xray taken within 3 months of diagnosis
• 25-OH Vitamin D
All the participants had serum 25-OH Vitamin D levels measured from venous blood within 30 days of diagnosis
• Vitamin B12
All the participants had serum Vitamin B12 levels measured from venous blood within 30 days of diagnosis
• Folic acid
All the participants had serum folic acid levels measured from venous blood within 30 days of diagnosis

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (22)

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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. — View Citation

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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. — View Citation

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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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vitamin B12 and Kellgren Lawrence Grade	Kruskal Wallis H Test was used to determine the relationship between Vitamin B12 and radiographical grade.	Baseline
Primary	Folic acid and Kellgren Lawrence Grade	Kruskal Wallis H Test was used to determine the relationship between Folic acid and radiographical grade.	Baseline