Supplementation With Vitamin D3 on Chronic Low Back Pain Patient
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D3 in the form of cholecalciferol.; Vegetable oil.
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: chronic low back pain; vitamin D; neurosurgery; functional; cognitive