Chronic Pain and Vitamin D

Not Applicable

• Conditions: Chronic Musculoskeletal Pain; Vitamin D Supplementation
• Interventions: Drug: vitamin D (cholecalciferol); Drug: Placebo, similar in appearance and taste to cholecalciferol

• Registration Number: NCT02002000
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in general practice. The possible causes are numerous and sometimes nonspecific. In some cases, the etiologic investigation of patients with non-systematized and chronic musculoskeletal pain can not highlight any organic cause. Several studies have shown a link between these symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D \< 20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D supplementation with few side effects. Nevertheless, it remains unknown and vitamin D deficiency is rarely considered as a possible etiology in patients with chronic pain. We hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal pain and deficient in vitamin D could improve painful symptoms. We aim to perform a double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain improvement after vitamin D supplementation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-11-29
• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Posted: 2013-12-05
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Women and men
• Aged 18-50 years (included)
• Consulting their general practitioner
• With chronic and diffuse musculoskeletal pain, without known etiology, lasting for at least 3 months
• With a 25(OH)vitamin D deficiency <20.8 ng/ml (52 nmol/l) at inclusion
• Who signed the consent form

Exclusion Criteria

• Identifiable source of pain requiring an appropriate specific management
• Disease or treatment that may interfere with the metabolism of vitamin D
• Current or previous hypercalcemia or hypercalciuria, treatment with digitalics and patients with history of nephrolithiasis
• Current treatment with vitamin D or at least one vitamin D vial taken over the previous 6 months
• Pregnancy or breastfeeding
• not affiliated to a social security system
• Refusal or inability to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D	vitamin D (cholecalciferol)	Patients receiving 3 doses of vitamin D (cholecalciferol)
Placebo	Placebo, similar in appearance and taste to cholecalciferol	Patients receiving 3 doses of placebo according to the same schedule as experimental arm

Primary Outcome Measures

Name	Time	Method
Proportion of patients in the two groups who reported a decrease in the overall pain after 3 months of treatment with vitamin D versus placebo.	3 months after inclusion	item 5 of the Brief Pain Inventory will be measured in each patient to assess the overall pain score at inclusion and after 3 month of treatment with vitamin D or placebo

Secondary Outcome Measures

Name	Time	Method
: Proportion of patients in both groups reporting an evolution of the minimum and the maximum of intensity of pain	3 months after inclusion	item 3 and 4 of the Brief Pain Inventory will be measured in each patient to assess the minimum and the maximum pain scores at inclusion, after 45 days and after 3 months of treatment with vitamin D or placebo
Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities	3 months after inclusion	item 9 of the Brief Pain Inventory will be measured in each patient to assess the score of the impact of pain on daily activities at inclusion, after 45 days and after 3 months of treatment with vitamin D or placebo
Proportion of patients reporting a decrease in the consumption of analgesic drugs	3 months after inclusion	Patients of both groups will be asked at inclusion, after 45 days and after 3 months, if they took analgesic drugs: name, class and dose of each treatment will be registered in a standardized questionnaire
Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages)	3 months after inclusion	Patients of both groups will be asked at inclusion, after 45 days and after 3 months, if they consulted any health care professional : which health care professional, how many time, the reason for consultation and work stoppages will be registered in a standardized questionnaire
Proportion of patients in both groups reporting an improvement in quality of life	3 months after inclusion	Quality of life will be measured in patients of both groups by the SF-36 questionnaire, at inclusion and after 90 days.

Trial Locations

Locations (1)

Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon; 🇫🇷 Lyon, France