Supplementation With Vitamin D3 on Chronic Low Back Pain Patient

NCT ID: NCT06082375

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-06-01

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.

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 inflammatory markers such as Interleukin-6; TumorNecrosisFactor-α. This measurement was performed in the University laboratory in Gdańsk according to a standard, generally accepted method for the determination of a given compound. The blood sample was taken by a qualified nurse. This measurement was repeated to control vitamin D levels and markers of inflammation:

• After 6 weeks of supplementation (before surgery);
• After 2 weeks of supplementation (after surgery);

Patients was supplemented with vitamin D or placebo for 6 weeks before surgery and was continue supplementation for 6 weeks after surgery. According to the value of the Body Mass Index, the dose of vitamin D will be appropriately selected for each group:

• Group 1 BMI 19-25 - 4000 IU
• Group 2 BMI 25-29,9- 6000 IU
• Group 3 BMI >30- 8000 IU

A person was appointed to coordinate the allocation of patients to the two groups. Patients was not informed whether they are receiving vitamin D or a placebo. The treating doctors, radiology specialists and the rest of the team was not know what group the patient is in. Within individual groups, patients was randomly assigned to:

• Group A - patients supplemented with placebo;
• Group B - patients supplemented with vitamin D3; Patients was informed about the purpose of the research and was receive. The patients diet was monitored during supplementation by a certified clinical dietitian using food diaries. The food diary is a basic tool for monitoring the diet of test subjects. After appropriate training, the respondents are able to fill in the diary on their own, writing down all the meals eaten during the day and snacks with drinks. It is a qualitative and quantitative method that allows you to analyze the diet so far and draw appropriate conclusions.

Patients from both groups who will not have contraindications to exercise, 2 weeks after surgery, was divided into a group for 6 weeks of home routine physical activity and a group not doing any additional physical activity.

• Group A1 - placebo supplementation + exercise
• Group A2 - placebo supplementation + no exercise
• Group B1 - supplementation with vit. D + exercises
• Group B2 - supplementation with vit. D + no exercise

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Vitamin D

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 in the form of cholecalciferol.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Vegetable oil.

Interventions

Vitamin D

Vitamin D3 in the form of cholecalciferol.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Vegetable oil.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

cholecalciferol

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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;

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Patryk Chromiec

Senior assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Kaczor, Professor

Role: STUDY_CHAIR

Medical University of Gdansk

Locations

Medical University

Gdansk, Pomeranian Voivodeship, Poland

Countries

Poland

Other Identifiers

SVITD

Identifier Type: -

Identifier Source: org_study_id