Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia
CompletedPhase 1, Phase 2NCT05008042
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: Mecobalamin 5 MG
- Other: Placebo Comparator : NaCl 9 mg/ml
- Sponsor
- Linnaeus University
- Collaborators
- Landstinget i Kalmar Län; Region Östergötland; Karolinska Institutet; Kronoberg County Council
- Start date
- 2019-02-06
- Primary completion
- 2024-03-26
- Sex
- Female
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Women aged 20-70 years * Swedish-speaking * Diagnosis of fibromyalgia * Safe method of contraception * Cobalamin / p (vitamin B12) should be \>250 pmol/L \< 800 pmol/L * Given consent to participate. Exclusion Criteria: * Previous treatment with B12 * Known hypersensitivity to the active substance Mecobalamin or an additive * Vegan as veganism can lead to B12 deficiency * Neuroleptics * Known heart, kidney or liver disease * Reynaud's phenomenon (white fingers) * Known neuropathy (impaired sensation) * Breastfeeding * Pregnancy or plan pregnancy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05008042