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

December 13, 2024 updated by: Carina Elmqvist, Linnaeus University

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Kronoberg
      • Växjö, Kronoberg, Sweden, 352 91
        • Linnaeus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Mecobalamin 5 MG
The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly
Placebo Comparator: 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.
Other: Placebo Comparator : NaCl 9 mg/ml
Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tolerance time
Time Frame: 24 weeks
Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain experience measured by a pressure algometry test
Time Frame: 24 weeks
Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
24 weeks
Possible pain change measured by a pressure algometry test
Time Frame: 24 weeks
Possible pain change measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
24 weeks
Subjective experience of pain measured using Numeric Rating Scale (NRS)
Time Frame: 24 weeks
Subjective experience of pain measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
24 weeks
Possible pain change measured using Numeric Rating Scale (NRS) 0-10
Time Frame: 24 weeks
Possible pain change measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
24 weeks
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)
Time Frame: 24 weeks
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
24 weeks
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10
Time Frame: 24 weeks
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
24 weeks
Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ).
Time Frame: 24 weeks
Activity level are assessed using questionnaire McGills Pain Questionnarie (MPQ). Short version score 0-45.
24 weeks
Quality of Life are assessed using questionnaires RAND-36.
Time Frame: 24 weeks
Quality of life are assessed using questionnaires RAND-36 score 0-100
24 weeks
Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).
Time Frame: 24 weeks
Experience of the effect of the drug, score 1-7
24 weeks
Cobalamin in plasma
Time Frame: 24 weeks
Control of vitamin B12 is done by measuring cobalamin in plasma.
24 weeks
Lived experiences of pain, health, suffering and well-being.
Time Frame: 24 weeks
Qualitative in-depth interviews will be conducted to capture women's lived experiences of pain, health, suffering and well-being.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linnaeus University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet
Region Östergötland
Kronoberg County Council
Landstinget i Kalmar Län

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carina Elmqvist, Ass prof, Linnaeus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EUDRACT 2015-005086-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Metadata and analysis scripts

IPD Sharing Time Frame

from 2025 - 2035

IPD Sharing Access Criteria

anyone requesting the metadata can access the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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