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

Last updated: February 27, 2024
Sponsor: Kuang Tien General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Treatment

Sideral® Sucrosomial Iron

Sucrosomial Iron

Iron chewable tablet

Clinical Study ID

NCT06279429
KTGH11137
  • Ages 20-80
  • All Genders

Study 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 Criteria

Inclusion

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) ≤12g/dL, ferritin ≤100 ng/mL, transferrin saturation ≤25%).
  4. Patients diagnosed as chronic insomnia by doctors according to internationalclassification of sleep disorders-third edition (ICSD-3).
  5. Subjects who voluntarily participate in the trial plan and complete the consent formafter explanation by doctors or project personnel.

Exclusion

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.

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Sideral® Sucrosomial Iron
Phase:
Study Start date:
May 31, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Kuang Tien General Hospital

    Taichung, 433
    Taiwan

    Active - Recruiting

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