Chronic Pain and Vitamin D

N/AUnknownNCT02002000

Hospices Civils de Lyon100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Chronic Musculoskeletal Pain Vitamin D Supplementation

vitamin D (cholecalciferol)DRUG

Patients from the vitamin D arm will receive an orally supplementation of 600 000 UI cholecalciferol in 3 doses: 200 000 UI at baseline (day 1), 200 000 UI on day 15 and 200 000 UI on day 30. Cholecalciferol will be presented in blisters, in a non-differentiable form in appearance and taste from placebo, either for the patient or the doctor

Patients from the placebo arm will receive 3 doses of placebo to be taken orally: one at baseline (day 1), one on day 15, one on day 30. Placebo will be presented in blisters in a non-differentiable form in appearance and taste from cholecalciferol either for the patient or the doctor.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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