[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439880":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":35,"responsibleParty":48,"collaborators":51,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Linnaeus University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mecobalamine 5 mg\u002Fml","ACTIVE_COMPARATOR","The active substance of vitamin B12 given in the study is Mecobalamin 5mg \u002F ml 2 ml ie 10 mg and is given intramuscularly.",[13],"Drug: Mecobalamin 5 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"NaCl 9mg\u002Fml","PLACEBO_COMPARATOR","Placebo substance given in the study is Sodium Chloride (NaCL) 9 mg \u002F ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly.",[19],"Other: Placebo Comparator : NaCl 9 mg\u002Fml",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Mecobalamin 5 MG","The Active substance of vitamin B12 is Mecobalamin 5 mg\u002Fml is given intramuscularly",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Comparator : NaCl 9 mg\u002Fml","Sodium Chloride (NaCL) 9 mg \u002F ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.",[15],[32],{"name":33,"affiliation":5,"role":34},"Carina Elmqvist, Ass prof","PRINCIPAL_INVESTIGATOR",[36],{"facility":5,"status":26,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":26},"Vaxjo","Kronoberg County","352 91","Sweden","SE",{"type":43,"coordinates":44},"Point",[45,46],14.80906,56.87767,{"lat":46,"lon":45},{"type":34,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Carina Elmqvist","Associate professor",[52,54,56,58],{"name":53,"class":6},"Landstinget i Kalmar Län",{"name":55,"class":6},"Region Östergötland",{"name":57,"class":6},"Karolinska Institutet",{"name":59,"class":60},"Kronoberg County Council","OTHER_GOV","100439880","phase-1-evaluation-of-the-efficiacy-of-mecobalamine-in-the-treatment-of-long-term-pain-in-women-diagnosed-with-fibromyalgia-100439880",false,"NCT05008042","Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia","Evaluation of the Efficiacy of Mecobalamine (Vit B12) in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia: Single-blind Randomized Controlled Trial With Three-month Follow up","Inclusion Criteria:\n\n* Women aged 20-70 years\n* Swedish-speaking\n* Diagnosis of fibromyalgia\n* Safe method of contraception\n* Cobalamin \u002F p (vitamin B12) should be \\>250 pmol\u002FL \\\u003C 800 pmol\u002FL\n* Given consent to participate.\n\nExclusion Criteria:\n\n* Previous treatment with B12\n* Known hypersensitivity to the active substance Mecobalamin or an additive\n* Vegan as veganism can lead to B12 deficiency\n* Neuroleptics\n* Known heart, kidney or liver disease\n* Reynaud's phenomenon (white fingers)\n* Known neuropathy (impaired sensation)\n* Breastfeeding\n* Pregnancy or plan pregnancy","FEMALE","18 Years","70 Years",{"count":72,"type":73},40,"ACTUAL","INTERVENTIONAL",[76,77],"PHASE1","PHASE2","Fibromyalgia causes long term pain where mostly women are affected. It is not entirely clear how vitamin B12 affects the human pain system, there are however many primary studies that indicate different interesting approaches. Considering that the receptor of NMDA is involved in both long-term pain and vitamin B12 deficiency its of most importance to evaluate whether vitamin B12 decreases the pain sensitivity and the experience of pain i.e hyperalgesia and allodynia, at persons with fibromyalgia.The aim of this study is therefore to evaluate the effect of Mecobalamin (vitamin B12), and describe lived experiences of pain, health, suffering and well-being in women with diagnosed fibromyalgia.",[80],"Fibromyalgia",[82,83,84,85,86],"Fibromyalgia,","Chronic pain,","Mekobalamin,","Randomized Controlled Trial","VitaminB12","COMPLETED","2024-12-13",{"date":90,"type":73},"2024-12-18",{"date":92,"type":73},"2019-02-06",{"date":94,"type":73},"2024-03-26",{"name":5,"class":6},1]