NCT07585045

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Apr 2026Feb 2027

Study Start

First participant enrolled

April 16, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 2, 2026

Last Update Submit

May 8, 2026

Conditions

Fibromyalgia

Keywords

FibromyalgiaMagnesium supplementRevised Fibromyalgia Impact Questionnaire

Outcome Measures

Primary Outcomes (1)

  • Revised Fibromyalgia Impact Questionnaire (FIQR)

    Changes in FIQR total score higher scores \>59 means severe disease and low scores\<39 means remission

    24 weeks

Secondary Outcomes (1)

  • Changes in FIQR subdomains

    24 weeks

Study Arms (2)

Standard Fibromyalgia treatment plus Magnesium glycinate supplement

EXPERIMENTAL

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.

Dietary Supplement: Magnesium glycinate

Standard FM treatment plus Vitamin supplement as placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Vitamins

Interventions

Magnesium glycinateDIETARY_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.

Standard Fibromyalgia treatment plus Magnesium glycinate supplement
VitaminsDIETARY_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.

Standard FM treatment plus Vitamin supplement as placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital, Lahore

Lahore, Punjab Province, 45000, Pakistan

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

magnesium diglycinateVitamins

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Masooma Hashmat, FCPS

    Shaikh Zayed Hospital, Lahore

    PRINCIPAL INVESTIGATOR

  • Ayesha Humayun, FCPS, PhD

    Shaikh Zayed Hospital, Lahore

    STUDY CHAIR

  • Aflak Rasheed, FCPS

    Shaikh Zayed Hospital, Lahore

    STUDY DIRECTOR

Central Study Contacts

Masooma Hashmat, FCPS

CONTACT

+923353053304masoomahashmat@gmail.com

Ayesha Humayun, FCPS, PhD

CONTACT

+923214343065drayeshah@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Fibromyalgia patients who shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics. 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 or a placebo (vitamin supplement) once daily at night for 24 weeks. 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, serum magnesium and renal panels will be measured.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR.

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 13, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 26, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
one year

Locations

PA(1)