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

NCT ID: NCT06279429

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-12-31

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.

Conditions

CKD; Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sideral® Sucrosomial Iron

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).

Group Type: EXPERIMENTAL

Sideral® Sucrosomial Iron

Intervention Type: DIETARY_SUPPLEMENT

Sucrosomial Iron 30mg

Placebo

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).

Group Type: ACTIVE_COMPARATOR

Iron chewable tablet

Intervention Type: DIETARY_SUPPLEMENT

Iron chewable tablet 100mg

Interventions

Sideral® Sucrosomial Iron

Sucrosomial Iron 30mg

Intervention Type: DIETARY_SUPPLEMENT

Iron chewable tablet

Iron chewable tablet 100mg

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuang Tien General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chun-pai Yang, MD

Chief, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chun-Pai Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Chief, Department of Neurology

Locations

Kuang Tien General Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chun-Pai Yang, MD

Role: CONTACT

neuralyung@gmail.com

+886-4-2665-1900

Facility Contacts

Nai-Hwei Wang, MD

Role: primary

fengcheese@gmail.com

886426885599

Other Identifiers

KTGH11137

Identifier Type: -

Identifier Source: org_study_id