Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Diagnostic Test: Direct digital radiography; Diagnostic Test: 25-OH Vitamin D; Diagnostic Test: Vitamin B12; Diagnostic Test: Folic acid

• Registration Number: NCT06267053
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-01-20
• Study Completion: 2024-01-20
• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kellgren Lawrence Grade	Vitamin B12	Patients are divided into four groups based on Kellgren lawrence stage
Kellgren Lawrence Grade	25-OH Vitamin D	Patients are divided into four groups based on Kellgren lawrence stage
Kellgren Lawrence Grade	Direct digital radiography	Patients are divided into four groups based on Kellgren lawrence stage
Kellgren Lawrence Grade	Folic acid	Patients are divided into four groups based on Kellgren lawrence stage

Primary Outcome Measures

Name	Time	Method
25-OH Vitamin D (25(OH)D) and Kellgren Lawrence Grade	Baseline	One way ANOVA was used to determine the relationship between 25(OH)D and radiographical grade.
Vitamin B12 and Kellgren Lawrence Grade	Baseline	Kruskal Wallis H Test was used to determine the relationship between Vitamin B12 and radiographical grade.
Folic acid and Kellgren Lawrence Grade	Baseline	Kruskal Wallis H Test was used to determine the relationship between Folic acid and radiographical grade.

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 Istanbul, Turkey