Comparative Efficiency of Three Vitamin D Supplements in Addressing Vitamin D Deficiency in Adults with Low Back Pain - VIDBA

Pulse Pharmaceuticals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

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•i.Vitamin D insufficient patients of either gender, aged between 18â??75 years with CLBP of 03-months or more with or without leg pain.
•ii.Vitamin D insufficiency will be identified with estimation of 25(OH)D in blood. Levels below 29 ng/ ml will be considered as vitamin D insufficiency.
•iii.The diagnosis of CLBP would be established based on signs, symptoms and MRI.
•iv.Patients are required to have language competency (English, Telugu, Kanada or Hindi) in order to complete the study related questionnaires which include a Modified Oswestry Disability Questionnaire (MODQ) to measure functional disability, work status, and the use of medication, and a visual analogue scale (VAS) to measure pain intensity.
•v.Patients having a pain score of atleast 05 as assessed on Visual Analogue Scale (VAS) at baseline.
•vi.Patients are required to have stable pain score for 03-months before recruitment and could be on any oral analgesic therapy.
•vii.Patients not responding to any medication and physical therapies.
•viii.Record will be made of patient history, physical examination, and laboratory tests.
•ix.Women of childbearing potential are required to receive a highly effective form of contraception.
•x.Subject and legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures.
•xi.All patients will provide signed Informed Consent.

•i.Patients who have taken Vitamin D supplementation during past 03-months.
•ii.Patients with a prior radiologically confirmed diagnosis of spondylolisthesis, disc herniation, spinal canal stenosis, vertebral compression fracture, spinal malformation or spinal injury.
•iii.Patients with a past history of spinal surgery.
•iv.Patients with established spinal tuberculosis or other spinal infections, malignancy, rheumatic disorder, osteomalacia, osteoporosis, osteoarthritis and metabolic bone disease (hypo- or hyperparathyroidism).
•v.Patients of diabetes mellitus, epilepsy, psychiatric diseases, substance abuse disorder, chronic renal disease, and medical or surgical disorders affecting Vitamin D metabolism (gastric surgery, chronic liver disease, renal failure, intestinal malabsorption, systemic infections, cancers etc.).
•vi. Neuropathic Pain Conditions are ruled out by using DN4 Questionnaire on screening day.
•vii.Malabsorption conditions such as Celiac disease are ruled out by Celiac Disease Questionnaire.
•viii.Patients consuming drugs altering bone metabolism like corticosteroid or bisphosphonates.
•ix.Pregnant and lactating mothers, and women intending pregnancy.
•x.Patients diagnosed with Illness/ infection on the day of the inclusion.
•xi.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.

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