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Recruiting NCT07585045

Effectiveness of Oral Magnesium Supplementation in Fibromyalgia Patients Not Responding to Standard Treatment

No phase Interventional Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnesium glycinate, Vitamins.
Who it may be relevant to
Registry conditions: Fibromyalgia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of Oral Magnesium Supplementation in Fibromyalgia Patients Not Responding to Standard Treatment: A Randomized Clinical Trial Using Revised Fibromyalgia Impact Questionnaire

Overview

Fibromyalgia is a complex widespread pain disorder. OBJECTIVES To evaluate the effectiveness of oral magnesium supplementation in reducing symptom severity among fibromyalgia patients who have not responded to standard treatment, using validated scoring systems such as the Fibromyalgia Impact Questionnaire Revised (FIQR).

Detailed description

This study is a prospective randomized controlled clinical trial aimed to evaluate the effectiveness of oral magnesium supplementation in reducing symptom severity among fibromyalgia patients who have not responded to standard treatment, using validated scoring systems such as the Fibromyalgia Impact Questionnaire Revised(FIQR).

METHODOLOGY Participants who meet ACR 2016 fibromyalgia criteria and have shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics and provided written informed consent. After confirming eligibility, baseline data-including demographics, medication history, serum magnesium and calcium levels, and renal function-will be collected, and each subject will complete the Fibromyalgia Impact Questionnaire Revised (FIQR). Using a computer generated block randomization, participants will be assigned to receive either oral magnesium glycinate 850 mg once daily at night or a placebo (vitamin supplement) daily for 24 weeks.

FOLLOW-UP Throughout the study, 4 weekly follow-ups will be advised to monitor adherence, side effects, and any changes in concurrent medications, while pill counts and patient diaries will be used to verify compliance. On 4 weekly follow up visits will repeat the FIQR, record adverse events; serum magnesium and renal panels will be re measured at week 12 and 24.

Interventions

  • Dietary supplement Magnesium glycinate
    Fibromyalgia patients who have shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics. Half participant randomly will be assigned to receive oral magnesium glycinate 850 mg once daily at night for 24 weeks.
  • Dietary supplement Vitamins
    Fibromyalgia patients who have shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics. Half participant will be randomly assigned to receive oral placebo (vitamin supplement) daily for 24 weeks.

Primary outcome measures

  • Revised Fibromyalgia Impact Questionnaire (FIQR) [Time frame: 24 weeks]
Secondary outcome measures (1)
  • Changes in FIQR subdomains [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with FM according to the American College of Rheumatology (ACR) 2016 criteria
  • Age: 18-65 years.
  • Not responding to conventional treatment (e.g., amitriptyline, duloxetine, pregabalin) for at least 8 weeks
  • Patients giving informed consent for enrollment in the study.

Exclusion criteria

  • 1- Patients with renal impairment 2- Pregnant or lactating women 3- Already on magnesium or other mineral supplements 4- Known cases of inflammatory arthritis or other chronic pain syndromes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Shaikh Zayed Hospital, Lahore — Lahore

Identifiers

NCT: NCT07585045 · TERC/SC/INT/2026/36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗