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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; CKD
• Intervention / Treatment: Dietary supplement: Sideral® Sucrosomial Iron; Dietary supplement: Iron chewable tablet

Detailed Description

As above.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Pai Yang, MD; Phone Number: +886-4-2665-1900; Email: neuralyung@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 433
    • Recruiting
    • Kuang Tien General Hospital
    • Contact: Nai-Hwei Wang, MD; Phone Number: 886426885599; Email: fengcheese@gmail.com
    • Principal Investigator: Chun-Pai Yang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Dietary supplement: Sideral® Sucrosomial Iron; Sucrosomial Iron 30mg
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).	Dietary supplement: Iron chewable tablet; Iron chewable tablet 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	Concentration of serum hemoglobin	week 0, 12
Ferritin	Concentration of serum ferritin	week 0, 12
Serum Iron	Concentration of serum Iron	week 0, 12
Transferrin Saturation	Concentration of serum transferrin Saturation	week 0, 12
Erythrocyte sedimentation rate	Concentration of serum erythrocyte sedimentation rate	week 0, 12
Insomnia Severity Index (ISI)	A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.	week 0, 12
Pittsburgh Sleep Quality Index (PSQI)	A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.	week 0, 12
Epworth sleepiness Scale (ESS)	A sleep-related questionnaire, ranging from 0 to 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.	week 0, 12

Collaborators and Investigators

• Sponsor: Kuang Tien General Hospital
• Investigators: Principal Investigator: Chun-Pai Yang, MD, Chief, Department of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Sleep Wake Disorders; Anemia, Iron-Deficiency; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: KTGH11137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No