Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Sucrosomial Iron 30mg
Iron chewable tablet 100mg
Kuang Tien General Hospital
Taichung, Taiwan
RECRUITINGInsomnia Severity Index (ISI)
A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Time frame: week 0, 12
Pittsburgh Sleep Quality Index (PSQI)
A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.
Time frame: week 0, 12
Epworth sleepiness Scale (ESS)
A sleep-related questionnaire, ranging from 0 to 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.
Time frame: week 0, 12
Hemoglobin
Concentration of serum hemoglobin
Time frame: week 0, 12
Ferritin
Concentration of serum ferritin
Time frame: week 0, 12
Serum Iron
Concentration of serum Iron
Time frame: week 0, 12
Transferrin Saturation
Concentration of serum transferrin Saturation
Time frame: week 0, 12
Erythrocyte sedimentation rate
Concentration of serum erythrocyte sedimentation rate
Time frame: week 0, 12
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