Supplementation With Vitamin D3 on Chronic Low Back Pain Patient

NCT06082375 | Completed

• 1 other identifier: SVITD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 Committee for Scientific Research at Medical University of Gdańsk (No. 525/2018), in accordance with the Declaration of Helsinki. We enrol 40 patient (aged ≥ 35), Patients diagnosed with chronic pain in the lumbar spine, qualified for surgical treatment at the Department of Neurosurgery Medicinal Unit in Gdańsk. Participation in the study was voluntary, and the condition for participation was obtaining informed consent from the patient.

Conditions

Chronic Low-back Pain

Keywords

chronic low back pain; vitamin D; neurosurgery; functional; cognitive

Outcome Measures

Primary Outcomes (6)

• Change in vitamin D3 status at blood serum

  Blood sample will be taken from patients to determine the status of vitamin D3, measurements of hydroxylated vitamin D at position 25 (25OHD3)

  Baseline and Week 8

• Change in vitamin Interleukin-6 status at blood serum

  Blood sample will be taken from patients to determine the status of interleukin-6, measurements to show changes in inflammation in the blood.

  Baseline and Week 8

• Change in vitamin TumorNecrosisFactor-alfa status at blood serum

  Blood sample will be taken from patients to determine the status of Tumor Necrosis Factor, measurements to show changes in inflammation in the blood.

  Baseline and Week 8

• Change in cognitive test Quality of life Short Form-36 questionnaire

  Validated cognitive tests assessing patients' quality of life. The Short Form - 36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: * vitality * physical functioning * bodily pain * general health perceptions * physical role functioning * emotional role functioning * social role functioning * mental health or emotional wellbeing

  Baseline and Week 8

• Change in cognitive test Chalder Fatigue Questionnaire

  Validated cognitive tests assessing patients' quality of life. The subject answers the questions using a 4-step scale (choosing between "better than usual," "no more than usual," "worse than usual" and "much worse than usual"). Answers to the first 7 items give an insight into the intensity of the physical fatigue and the next 4 give a picture of the mental fatigue. The overall score is obtained by adding all the items. There are 2 scoring systems: * a Likert system, where the subject's answers are evaluated by awarding 0, 1, 2 or 3 pts, giving a maximum of 33 pts; * a bimodal system, which ignores the severity of responses and categorizes the answers as a "problem" ("more than usual" and "much more than usual" - 1 pt) or "no problem" ("less than usual" and "no more than usual" - 0 pt), giving a maximum of 11 pts.

  Baseline and Week 8

• Change in functional test Up&Go

  Up\&Go Test aimed at checking the task completion time as a functional element. Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. For password: "Go," the patient begins: 1\. Stand up from the chair. 2. Walk to the line on the floor at your normal pace. 3\. Turn. 4. Walk back to the chair at your normal pace. 5. Sit down again. On the word "Go," begin timing. Stop timing after patient sits back down. Record time: time in Seconds.

  Baseline and Week 8

Study Arms (2)

Vitamin D

EXPERIMENTAL

Individually adapted to each participant based on BMI, dose of vitamin D3 in drops. 1. BMI 19-25 - 4000 IU 2. BMI 25-29,9- 6000 IU 3. BMI \>30- 8000 IU

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

The placebo group will receive drops containing vegetable oil in the same bottles as vitamin D3.

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D3 in the form of cholecalciferol.

Also known as: cholecalciferol

Vitamin D

Placebo DIETARY_SUPPLEMENT

Vegetable oil.

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University

Gdansk, Pomeranian Voivodeship, 80-210, Poland

Location

MeSH Terms

Interventions

Vitamin D; Cholecalciferol

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Jan Kaczor, Professor

  Medical University of Gdansk

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior assistant professor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 13, 2023
• Study Start: August 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2022
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

PL (1)