Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis

February 16, 2024 updated by: Filiz Yildiz Aydin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigation of the Relationship Between Vitamin B12, Folic Acid and 25 OH D Levels 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kellgren Lawrence Grade
Patients are divided into four groups based on Kellgren lawrence stage
Diagnostic test: Direct digital radiography
All the participants had anterior posterior and lateral knee xray taken within 3 months of diagnosis
Diagnostic test: 25-OH Vitamin D
All the participants had serum 25-OH Vitamin D levels measured from venous blood within 30 days of diagnosis
Diagnostic test: Vitamin B12
All the participants had serum Vitamin B12 levels measured from venous blood within 30 days of diagnosis
Diagnostic test: Folic acid
All the participants had serum folic acid levels measured from venous blood within 30 days of diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Study Chair: Arda Can KASAP, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  • Principal Investigator: Filiz YILDIZ AYDIN, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  • Study Chair: Sibel CAGLAR, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

January 20, 2024

Study Completion (Actual)

January 20, 2024

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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