Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-01-13 @ 3:44 PM
Study NCT ID:
NCT02002000
Status:
UNKNOWN
Last Update Posted:
2013-12-10
First Post:
2013-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Pain and Vitamin D
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-09', 'studyFirstSubmitDate': '2013-11-29', 'studyFirstSubmitQcDate': '2013-11-29', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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'}], 'secondaryOutcomes': [{'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', 'description': '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'}, {'measure': 'Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities', 'timeFrame': '3 months after inclusion', 'description': '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'}, {'measure': 'Proportion of patients reporting a decrease in the consumption of analgesic drugs', 'timeFrame': '3 months after inclusion', 'description': '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'}, {'measure': 'Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages)', 'timeFrame': '3 months after inclusion', 'description': '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'}, {'measure': 'Proportion of patients in both groups reporting an improvement in quality of life', 'timeFrame': '3 months after inclusion', 'description': 'Quality of life will be measured in patients of both groups by the SF-36 questionnaire, at inclusion and after 90 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D deficiency', 'Musculoskeletal pain', 'Vitamin D supplementation'], 'conditions': ['Chronic Musculoskeletal Pain', 'Vitamin D Supplementation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men\n* Aged 18-50 years (included)\n* Consulting their general practitioner\n* With chronic and diffuse musculoskeletal pain, without known etiology, lasting for at least 3 months\n* With a 25(OH)vitamin D deficiency \\<20.8 ng/ml (52 nmol/l) at inclusion\n* Who signed the consent form\n\nExclusion Criteria:\n\n* Identifiable source of pain requiring an appropriate specific management\n* Disease or treatment that may interfere with the metabolism of vitamin D\n* Current or previous hypercalcemia or hypercalciuria, treatment with digitalics and patients with history of nephrolithiasis\n* Current treatment with vitamin D or at least one vitamin D vial taken over the previous 6 months\n* Pregnancy or breastfeeding\n* not affiliated to a social security system\n* Refusal or inability to give consent'}, 'identificationModule': {'nctId': 'NCT02002000', 'acronym': 'DOVID', 'briefTitle': 'Chronic Pain and Vitamin D', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice', 'orgStudyIdInfo': {'id': '2013-802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitamin D', 'description': 'Patients receiving 3 doses of vitamin D (cholecalciferol)', 'interventionNames': ['Drug: vitamin D (cholecalciferol)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Patients receiving 3 doses of placebo according to the same schedule as experimental arm', 'interventionNames': ['Drug: Placebo, similar in appearance and taste to cholecalciferol']}], 'interventions': [{'name': 'vitamin D (cholecalciferol)', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['vitamin D']}, {'name': 'Placebo, similar in appearance and taste to cholecalciferol', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69424', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Anne-Marie SCHOTT, Pr', 'role': 'CONTACT', 'email': 'anne-marie.schott-pethelaz@chu-lyon.fr', 'phone': '4 72 11 53 71', 'phoneExt': '+33'}], 'facility': 'Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Anne-Marie SCHOTT, Pr', 'role': 'CONTACT', 'email': 'anne-marie.schott-pettelaz@chu-lyon.fr', 'phone': '472115371', 'phoneExt': '+33'}, {'name': 'Julie Haesebaert', 'role': 'CONTACT', 'email': 'julie.haesebaert@chu-lyon.fr', 'phone': '472115371', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Anne-Marie SCHOTT, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}