Effect of Sucrosomial Iron on Insomnia in Chronic Kidney Disease Patients

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

This study is testing if a new type of iron supplement can help people with chronic kidney disease and iron deficiency sleep better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Kuang Tien General Hospital (Academic / other)
• Locations: 1 site (Taichung)
• Trial ID: NCT06279429 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets in treating insomnia among patients with chronic kidney disease (CKD) and iron deficiency anemia. Insomnia is a common but often unrecognized issue in CKD patients, which can significantly impact their quality of life. The trial aims to determine if these iron supplements can improve sleep disorders in this specific patient population. Participants will be monitored for changes in their sleep patterns and overall health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20-80 with chronic kidney disease and iron deficiency anemia who have been diagnosed with chronic insomnia.

Not a fit: Patients who are currently taking iron supplements or have non-chronic insomnia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for improving sleep quality in CKD patients suffering from insomnia.

How similar studies have performed: While there is limited data on the specific use of Sucrosomial Iron for insomnia in CKD patients, similar studies have shown that addressing iron deficiency can improve overall health outcomes in this population.

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.

Where this trial is running

Taichung

• Kuang Tien General Hospital — Taichung, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chun-Pai Yang, MD — Chief, Department of Neurology
• Study coordinator: Chun-Pai Yang, MD

Conditions CKD; Sleep Disorder