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Completed

NCT Number: NCT06267053

Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct digital radiography

Diagnostic Test

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

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

Vitamin B12

Diagnostic Test

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

Folic acid

Diagnostic Test

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

Primary outcomes

  1. 25-OH Vitamin D (25(OH)D) and Kellgren Lawrence Grade

    Time frame: Baseline

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

  2. Vitamin B12 and Kellgren Lawrence Grade

    Time frame: Baseline

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

  3. Folic acid and Kellgren Lawrence Grade

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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