Chronic Musculoskeletal Pain, Vitamin D Supplementation
Conditions
Keywords
Vitamin D deficiency, Musculoskeletal pain, Vitamin D supplementation
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.
Interventions
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
DRUGPlacebo, similar in appearance and taste to cholecalciferol
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| : 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. |
Countries
France
Contacts
Primary ContactAnne-Marie SCHOTT, Pr
Backup ContactJulie Haesebaert
Outcome results
None listed