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

Sponsor
Shaikh Zayed Hospital, Lahore
Study ID
NCT07585045
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnesium glycinate — DIETARY_SUPPLEMENT
    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.
  • Vitamins — DIETARY_SUPPLEMENT
    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.

Study Details

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).

Key Dates

First listed
May 13, 2026
Start date
Apr 16, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Feb 26, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Fibromyalgia treatment plus Magnesium glycinate supplement
    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 magnesium glycinate 850 mg once daily at night for 24 weeks. \- 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 FIQ, WPI/SSS, and record adverse events; serum magnesium and renal panels will be re measured at week 12 and 24.
  • Placebo Comparator: Standard FM treatment plus Vitamin supplement as placebo
    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 vitamin supplement as placebo once daily at night for 24 weeks. \- 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 FIQ, WPI/SSS, and record adverse events; serum magnesium and renal panels will be re measured at week 12 and 24.

Primary Outcome Measure

Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: 24 weeks ]

Central Contacts

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