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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sideral® Sucrosomial Iron | Experimental | The study subjects continued to take Sucrosomial Iron 30mg supplements every day, 2 capsules a day, one 30 minutes after breakfast and dinner, for 12 consecutive weeks. During the study period, none of them used erythropoiesis stimulating agent (ESA). |
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| Placebo | Active Comparator | The study subjects continued to take Iron chewable tablet 100mg supplements every day, 2 capsules a day, one 30 minutes after breakfast and dinner, for 12 consecutive weeks. During the study period, none of them used erythropoiesis stimulating agent (ESA). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sideral® Sucrosomial Iron | Dietary Supplement | Sucrosomial Iron 30mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia. | 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. | 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. | week 0, 12 |
| Hemoglobin | Concentration of serum hemoglobin | week 0, 12 |
| Ferritin | Concentration of serum ferritin | week 0, 12 |
| Serum Iron | Concentration of serum Iron | week 0, 12 |
| Transferrin Saturation | Concentration of serum transferrin Saturation | week 0, 12 |
| Erythrocyte sedimentation rate | Concentration of serum erythrocyte sedimentation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Pai Yang, MD | Contact | +886-4-2665-1900 | neuralyung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chun-Pai Yang, MD | Chief, Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuang Tien General Hospital | Recruiting | Taichung | 433 | Taiwan |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Iron chewable tablet |
| Dietary Supplement |
Iron chewable tablet 100mg |
|
| week 0, 12 |
| D001523 | Mental Disorders |