Clinical trial NCT06267053: Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis
Official title: Investigation of the Relationship Between Vitamin B12, Folic Acid and 25 OH D Levels and Radiologic Stage in Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Vitamin B12
Folate
Vitamin D
Gonarthrosis
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-20
Enrollment: 104
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 25-OH Vitamin D (25(OH)D) and Kellgren Lawrence Grade
timeFrame: Baseline
measure: Vitamin B12 and Kellgren Lawrence Grade
timeFrame: Baseline
measure: Folic acid and Kellgren Lawrence Grade
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study officials:
affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
name: Filiz YILDIZ AYDIN
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
name: Sibel CAGLAR
role: STUDY_CHAIR
affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
name: Arda Can KASAP
role: STUDY_CHAIR
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