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

NCT ID: NCT05008042

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2024-03-26

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Keywords

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Fibromyalgia, Chronic pain, Mekobalamin, Randomized Controlled Trial VitaminB12

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with Three-month follow up
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mecobalamine 5 mg/ml

The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly.

Group Type ACTIVE_COMPARATOR

Mecobalamin 5 MG

Intervention Type DRUG

The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly

NaCl 9mg/ml

Placebo substance given in the study is Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly.

Group Type PLACEBO_COMPARATOR

Placebo Comparator : NaCl 9 mg/ml

Intervention Type OTHER

Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.

Interventions

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Mecobalamin 5 MG

The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly

Intervention Type DRUG

Placebo Comparator : NaCl 9 mg/ml

Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Landstinget i Kalmar Län

OTHER

Sponsor Role collaborator

Region Östergötland

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Kronoberg County Council

OTHER_GOV

Sponsor Role collaborator

Linnaeus University

OTHER

Sponsor Role lead

Responsible Party

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Carina Elmqvist

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carina Elmqvist, Ass prof

Role: PRINCIPAL_INVESTIGATOR

Linnaeus University

Locations

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Linnaeus University

Vaxjo, Kronoberg County, Sweden

Site Status

Countries

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Sweden

References

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Sall Hansson K, Lindqvist G, Stening K, Fohlman J, Wojanowski A, Ponten M, Jensen K, Gerdle B, Elmqvist C. Efficacy of mecobalamin (vitamin B12) in the treatment of long-term pain in women diagnosed with fibromyalgia: protocol for a randomised, placebo-controlled trial. BMJ Open. 2023 Mar 30;13(3):e066987. doi: 10.1136/bmjopen-2022-066987.

Reference Type DERIVED
PMID: 36997252 (View on PubMed)

Other Identifiers

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EUDRACT 2015-005086-23

Identifier Type: -

Identifier Source: org_study_id