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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults aged 20-80.

• Chronic kidney disease (CKD) patients.

• Iron deficiency anemia (male haemoglobin (Hb) ≤13 g/dL; female haemoglobin (Hb) ≤12 g/dL, ferritin ≤100 ng/mL, transferrin saturation ≤25%).

• Patients diagnosed as chronic insomnia by doctors according to international classification of sleep disorders-third edition (ICSD-3).

• Subjects who voluntarily participate in the trial plan and complete the consent form after explanation by doctors or project personnel.

Locations
Other Locations
Taiwan
Kuang Tien General Hospital
RECRUITING
Taichung
Contact Information
Primary
Chun-Pai Yang, MD
neuralyung@gmail.com
+886-4-2665-1900
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 100
Treatments
Experimental: 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).
Active_comparator: 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).
Sponsors
Leads: Kuang Tien General Hospital

This content was sourced from clinicaltrials.gov