CKD, Sleep Disorder
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSideral® Sucrosomial Iron
Sucrosomial Iron 30mg
DIETARY_SUPPLEMENTIron chewable tablet
Iron chewable tablet 100mg
Sponsors
Kuang Tien General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 20-80. 2. Chronic kidney disease (CKD) patients. 3. Iron deficiency anemia (male haemoglobin (Hb) ≤13 g/dL; female haemoglobin (Hb) ≤12 g/dL, ferritin ≤100 ng/mL, transferrin saturation ≤25%). 4. Patients diagnosed as chronic insomnia by doctors according to international classification of sleep disorders-third edition (ICSD-3). 5. Subjects who voluntarily participate in the trial plan and complete the consent form after explanation by doctors or project personnel.
Exclusion criteria
1. Patients taking iron supplements. 2. Patients with non-chronic insomnia. 3. Patients with alcoholism within one year. 4. People with other serious diseases. 5. Pregnant women or women who are still breastfeeding. 6. Those who are unable to cooperate with the test progress. 7. Patients with autoimmune abnormalities (ex. inflammatory bowel disease). 8. People with non-iron deficiency anemia (ex. thalassemia). 9. Those who are taking sleeping pills or sedatives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | week 0, 12 | A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia. |
| Pittsburgh Sleep Quality Index (PSQI) | week 0, 12 | A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality. |
| Epworth sleepiness Scale (ESS) | week 0, 12 | 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. |
| Hemoglobin | week 0, 12 | Concentration of serum hemoglobin |
| Ferritin | week 0, 12 | Concentration of serum ferritin |
| Serum Iron | week 0, 12 | Concentration of serum Iron |
| Transferrin Saturation | week 0, 12 | Concentration of serum transferrin Saturation |
| Erythrocyte sedimentation rate | week 0, 12 | Concentration of serum erythrocyte sedimentation rate |
Countries
Taiwan
Contacts
Primary ContactChun-Pai Yang, MD
Outcome results
None listed