Clinical trial NCT02002000: Chronic Pain and Vitamin D
Official title: Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Vitamin D Supplementation
Keywords: Vitamin D deficiency
Musculoskeletal pain
Vitamin D supplementation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 months after inclusion
Secondary outcomes:
measure: : Proportion of patients in both groups reporting an evolution of the minimum and the maximum of intensity of pain
timeFrame: 3 months after inclusion
measure: Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities
timeFrame: 3 months after inclusion
measure: Proportion of patients reporting a decrease in the consumption of analgesic drugs
timeFrame: 3 months after inclusion
measure: Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages)
timeFrame: 3 months after inclusion
measure: Proportion of patients in both groups reporting an improvement in quality of life
timeFrame: 3 months after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
Study officials:
affiliation: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
name: Anne-Marie SCHOTT, Pr
role: PRINCIPAL_INVESTIGATOR
References: