Chronic pain and vitamin D: A randomized controlled trial in primary care medicine in France, the Dovid study - DOVID

INTERVENTION: Trade Name: UVEDOSE Pharmaceutical Form: Oral liquid INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: CHOLECALCIFEROL Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 100000‐ Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use CONDITION: Chronic pain; MedDRA version: 18.0 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867 Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] PRIMARY OUTCOME: Main Objective: To estimate, at 3 months, the efficacy of vitamin D supplementation versus placebo on reducing the intensity of non-systematized musculoskeletal pain in patients aged 18 to 50 years with vitamin D deficiency. Primary endpoint(s): Pain intensity in general, at 3 months, measured by item 5 of the BPI scale. Secondary Objective: To estimate the efficacy of vitamin D supplementation versus placebo, at 3 months, on: 1/ the change in maximum and minimum pain intensity. 2/ the reduction in the impact of pain on daily activities; 3/ the reduction in the consumption of pain medication; 4/ the reduction in healthcare consumption (consultations and sick leave); 5/ the improvement in quality of life as measured by the SF-36 questionnaire; Timepoint(s) of evaluation of this endpoint: 3 months after inclusion SECONDARY OUTCOME: Secondary endpoint(s): o Other pain assessment items from the BPI scale (maximum intensity - item 3, minimum intensity - item 4, intensity at the time of completion - item 6), measured on days 1, 45 and 90; o Impact of pain on daily activities (discomfort caused by pain - item 9 of the BPI), measured on days 1, 45 and 90; • Pain medication use (quantity, frequency, and duration): This data will be collected during telephone interviews on days 1, 45, and 90 using a standardized questionnaire. The names, classes, and dosages of the medications will be recorded. Patients will receive a logbook to record any changes to their pain medication between calls. • Healthcare use (medical and paramedical consultations, sick leave): This data will be collected during telephone interviews on days 1, 45, and 90 using a standardized questionnaire. The number of consultations, the type of professional (paramedical or medical, general practitioner or specialist, specialty), the reason for consultation, the number of days of sick leave, and the reason for sick leave will be recorded. Patients will receive a logbook to record this data between calls. • Quality of life, measured using the validated Short Form 36 (SF36) quality of life questionnaire, on days 1 and 90. Timepoint(s) of evaluation of this endpoint: Day 1, Day 45 and Day 90 INCLUSION CRITERIA: - Men and women aged 18 to 50 years - Presenting with chronic diffuse pain: Non-systematized musculoskeletal pain, for which an etiological workup has been previously carried out and was negative - Evolving for at least two months - Documented by a standardized questionnaire - With or without taking analgesic medication - Presenting with a vitamin D deficiency documented by a 25(OH)vitamin D level <20.8 ng/L or 52 nmol/L at the inclusion visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no