NCT03825393

Brief Summary

The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 7, 2020

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

January 26, 2019

Results QC Date

May 26, 2019

Last Update Submit

April 9, 2024

Conditions

Keywords

Fibromyalgia Syndrome, Ferritin, Sleep

Outcome Measures

Primary Outcomes (2)

  • Pitsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes "poor" sleep from "good" sleep. minimum score 1 maximum score 9 ≥5 total points in PSQI mean "poor" sleep. \<5 total points in PSQI mean good sleep.

    1 year

  • Ferritin Level

    Iron deficiency marker

    1 year

Secondary Outcomes (3)

  • Fibromyalgia Impact Questionnarie Scores

    1 year

  • Beck Depression Inventory

    1 year

  • Beck Anxiety Inventory

    1 year

Study Arms (2)

Fibromyalgia

Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College

Control

Non-anemic women without a FMS diagnosis

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This sectional study included 100 female patients older than 18 years of age who presented to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.

You may qualify if:

  • Fibromyalgi syndrome patients
  • ferritin levels were measured within the last four weeks

You may not qualify if:

  • parenteral or enteral iron usage in last four weeks
  • hemoglobin level was less than 12 g/dl
  • infection
  • malignity
  • active inflammatory arthritis
  • serious skin variations
  • serious peripheral vascular disease
  • iron storing disorder
  • pregnant or lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Results Point of Contact

Title
Dr.Sevil Okan
Organization
Tokat State Hospital

Study Officials

  • sevil okan

    Doctor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 26, 2019

First Posted

January 31, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

April 10, 2024

Results First Posted

April 7, 2020

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share