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Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia | Clinical Trials | Clareo Health

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

NCT06279429•Kuang Tien General Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Kuang Tien General Hospital

Taichung, Taiwan

Key Dates

Start Date

May 31, 2022

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

February 29, 2024

Enrollment

100

ESTIMATED participants

Conditions

CKDSleep Disorder

Interventions

Sideral® Sucrosomial Iron

DIETARY_SUPPLEMENT

Iron chewable tablet

DIETARY_SUPPLEMENT

Contacts

Chun-Pai Yang, MD

CONTACT

+886-4-2665-1900 neuralyung@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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