Oral magnesium for people with fibromyalgia who haven't improved on standard medicines
Effectiveness of Oral Magnesium Supplementation in Fibromyalgia Patients Not Responding to Standard Treatment: A Randomized Clinical Trial Using Revised Fibromyalgia Impact Questionnaire
This trial tests whether taking a daily oral magnesium supplement helps people with fibromyalgia whose symptoms have not improved after standard medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shaikh Zayed Hospital, Lahore Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07585045 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled trial enrolling adults who meet the ACR 2016 criteria for fibromyalgia and who have not improved after at least eight weeks on a single standard therapy (amitriptyline, duloxetine, or pregabalin). Participants are randomized by block to receive magnesium glycinate 850 mg nightly or a placebo vitamin for 24 weeks, with baseline and repeated outcome measurement using the Revised Fibromyalgia Impact Questionnaire (FIQR). Safety monitoring includes serum magnesium and renal panels at baseline, week 12, and week 24, and adherence is tracked with pill counts and patient diaries during four-weekly clinic visits. The trial is conducted at Shaikh Zayed Hospital, Lahore, with recruitment from rheumatology clinics and written informed consent obtained from all participants.
Who should consider this trial
Good fit: Adults aged 18–65 with fibromyalgia by ACR 2016 criteria who have shown no improvement after at least eight weeks on a single standard therapy and who have normal renal function and are not already taking magnesium supplements are ideal candidates.
Not a fit: People with renal impairment, pregnant or lactating women, those already taking magnesium or other mineral supplements, or those with inflammatory arthritis or other chronic pain syndromes are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, a simple, low-cost oral magnesium supplement could reduce symptom severity and improve daily functioning in people with fibromyalgia who do not respond to standard medications.
How similar studies have performed: Prior small trials and pilot studies of magnesium in fibromyalgia have reported mixed results and limited evidence, so the approach has some preliminary support but is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients diagnosed with FM according to the American College of Rheumatology (ACR) 2016 criteria 2. Age: 18-65 years. 3. Not responding to conventional treatment (e.g., amitriptyline, duloxetine, pregabalin) for at least 8 weeks 4. 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
Where this trial is running
Lahore, Punjab Province
- Shaikh Zayed Hospital, Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Masooma Hashmat, FCPS — Shaikh Zayed Hospital, Lahore
- Study coordinator: Masooma Hashmat, FCPS
- Email: masoomahashmat@gmail.com
- Phone: +923353053304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.