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

Launched by KUANG TIEN GENERAL HOSPITAL · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a specific type of iron supplement called Sideral® Sucrosomial Iron on sleep problems, particularly insomnia, in patients with chronic kidney disease (CKD) who also have iron deficiency anemia. Insomnia is a common issue for CKD patients and can significantly impact their quality of life. The trial aims to find out if this iron supplement can help improve sleep quality in these individuals.

To participate in the study, you need to be an adult between the ages of 20 and 80 who has CKD and iron deficiency anemia, as defined by certain blood tests. It's important that you have been diagnosed with chronic insomnia by a healthcare provider. However, if you are currently taking iron supplements, sleeping pills, or have other serious health issues, you may not be eligible. Participants in the trial will take the iron supplements and will be monitored for their sleep patterns and overall health to see if there is any improvement in their insomnia. This is a great opportunity for those struggling with sleep issues related to CKD to potentially find relief.

Gender

ALL

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.