Trial Outcomes & Findings for Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome (NCT NCT03825393)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

1 year

Results posted on

2024-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Fibromiyalgia 100 Fibromyalgia Patient Group	Control 100 Control Group
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fibromiyalgia n=100 Participants 100 Fibromyalgia Patient Group	Control n=100 Participants 100 Control Group	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=100 Participants	0 Participants n=100 Participants	0 Participants n=200 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=100 Participants	100 Participants n=100 Participants	200 Participants n=200 Participants
Age, Categorical >=65 years	0 Participants n=100 Participants	0 Participants n=100 Participants	0 Participants n=200 Participants
Sex: Female, Male Female	100 Participants n=100 Participants	100 Participants n=100 Participants	200 Participants n=200 Participants
Sex: Female, Male Male	0 Participants n=100 Participants	0 Participants n=100 Participants	0 Participants n=200 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	100 Participants n=100 Participants	100 Participants n=100 Participants	200 Participants n=200 Participants
ferritin level	20.95 ng/ml n=100 Participants	34.91 ng/ml n=100 Participants	32.92 ng/ml n=200 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 100 This index applied only Firomyalgia syndrome group

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia n=100 Participants Fibromyalgia syndrome group	Fibromyalgia Fibromyalgia syndrome
Pitsburgh Sleep Quality Index	8.3 score on a questionnarie Standard Deviation 3.77	—

PRIMARY outcome

Timeframe: 1 year

Population: 200

Iron deficiency marker

Outcome measures

Outcome measures
Measure	Fibromyalgia n=100 Participants Fibromyalgia syndrome group	Fibromyalgia n=100 Participants Fibromyalgia syndrome
Ferritin Level	34.91 ng/ml Interval 17.87 to 55.12	20.95 ng/ml Interval 11.75 to 39.55

SECONDARY outcome

Timeframe: 1 year

Population: 100 This questionnarie applied only Firomyalgia syndrome group

Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality. mimimum score 0 maximum score 100 higher scores shows poor functionality.

Outcome measures

Outcome measures
Measure	Fibromyalgia n=100 Participants Fibromyalgia syndrome group	Fibromyalgia Fibromyalgia syndrome
Fibromyalgia Impact Questionnarie Scores	61.69 score on a questionnarie Standard Deviation 17.31	—

SECONDARY outcome

Timeframe: 1 year

Population: 100 This questionnarie applied only Firomyalgia syndrome group

Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression). minimum 0 maximum 63 points higher scores mean worse outcome.

Outcome measures

Outcome measures
Measure	Fibromyalgia n=100 Participants Fibromyalgia syndrome group	Fibromyalgia Fibromyalgia syndrome
Beck Depression Inventory	15.73 score on a questionnarie Standard Deviation 9.76	—

SECONDARY outcome

Timeframe: 1 year

Population: 100 This inventory applied only Firomyalgia syndrome group

Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety). minimum 0 maximum 63 points higher scores mean worse outcome

Outcome measures

Outcome measures
Measure	Fibromyalgia n=100 Participants Fibromyalgia syndrome group	Fibromyalgia Fibromyalgia syndrome
Beck Anxiety Inventory	22.58 score on a questionnarie Standard Deviation 11.14	—

Adverse Events

Fibromiyalgia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Sevil Okan

Tokat State Hospital

Phone: 5308211797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place