Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia

Sleep Disorder Clinical Trial

Official title:

Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279429
• Other study ID #: KTGH11137
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• CKD
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sleep Disorder
• Sleep Wake Disorders

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