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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06279429
Other study ID # KTGH11137
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2022
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Kuang Tien General Hospital
Contact Chun-Pai Yang, MD
Phone +886-4-2665-1900
Email neuralyung@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Dietary Supplement:
Sideral® Sucrosomial Iron
Sucrosomial Iron 30mg
Iron chewable tablet
Iron chewable tablet 100mg

Locations

Country Name City State
Taiwan Kuang Tien General Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
Kuang Tien General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Hemoglobin Concentration of serum hemoglobin week 0, 12
Primary Ferritin Concentration of serum ferritin week 0, 12
Primary Serum Iron Concentration of serum Iron week 0, 12
Primary Transferrin Saturation Concentration of serum transferrin Saturation week 0, 12
Primary Erythrocyte sedimentation rate Concentration of serum erythrocyte sedimentation rate week 0, 12
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