Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Linnaeus University
• Collaborators: Karolinska Institutet; Kronoberg County Council; Landstinget i Kalmar Län; Region Östergötland

Criteria

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