Status:
COMPLETED
Supplementation With Vitamin D3 on Chronic Low Back Pain Patient
Lead Sponsor:
Medical University of Gdansk
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The study was designed as a randomized double-blind placebo-controlled clinical trial with 8-week Vitamin D3 and physical activity intervention. The protocol was approved by Independent Bioethics Comm...
Detailed Description
Before starting supplementation, a blood sample was taken from patients to determine the status of vitamin D3, measurements of hydroxylated vitamin D at position 25 (25OHD3) and monitoring of inflamma...
Eligibility Criteria
Inclusion
- Pain in the lumbar spine that lasts more than 6 months (diagnosed by signs and symptoms, and tests such as magnetic resonance imaging (MRI));
- Failure to respond to medications and physical therapies;
- Visual Analog Pain Scale (VAS), (0-100) score greater than or equal to 50;
- Numerical Rating Scale (NRS);
Exclusion
- Rheumatoid arthritis;
- Diagnosed mental illness;
- Drugs;
- Metabolic bone diseases (hypo or hyperparasitism);
- Chronic kidney diseases and diseases affecting vitamin D metabolism (stomach surgery, chronic liver diseases, kidney failure, malabsorption disorders, systemic infection, tumors, etc.)
- Medicines that alter the metabolism of bones such as corticosteroids or bisphosphonates;
- Vitamin D supplements in the last 3 months;
- BMI: less than 19;
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06082375
Start Date
August 1 2019
End Date
June 1 2022
Last Update
October 13 2023
Active Locations (1)
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1
Medical University
Gdansk, Pomeranian Voivodeship, Poland, 80-210