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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D | Experimental | Patients receiving 3 doses of vitamin D (cholecalciferol) |
|
| Placebo | Experimental | Patients receiving 3 doses of placebo according to the same schedule as experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| : Proportion of patients in both groups reporting an evolution of the minimum and the maximum of intensity of pain | 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 | 3 months after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Marie SCHOTT, Pr | Contact | 472115371 | +33 | anne-marie.schott-pettelaz@chu-lyon.fr |
| Julie Haesebaert | Contact | 472115371 | +33 | julie.haesebaert@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie SCHOTT, Pr | Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon | Lyon | 69424 | France |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Placebo, similar in appearance and taste to cholecalciferol | Drug | 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. |
|
| Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities | 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 | 3 months after inclusion |
| Proportion of patients reporting a decrease in the consumption of analgesic drugs | 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 | 3 months after inclusion |
| Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages) | 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 | 3 months after inclusion |
| Proportion of patients in both groups reporting an improvement in quality of life | Quality of life will be measured in patients of both groups by the SF-36 questionnaire, at inclusion and after 90 days. | 3 months after inclusion |
| D009750 |
| Nutritional and Metabolic Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |