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

Not Applicable

Recruiting

• Conditions: CKD; Sleep Disorder
• Interventions: Dietary Supplement: Sideral® Sucrosomial Iron; Dietary Supplement: Iron chewable tablet

• Registration Number: NCT06279429
• Lead Sponsor: Kuang Tien General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2024-01-24
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sideral® Sucrosomial Iron	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).
Placebo	Iron chewable tablet	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).

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	week 0, 12	A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Hemoglobin	week 0, 12	Concentration of serum hemoglobin
Ferritin	week 0, 12	Concentration of serum ferritin
Serum Iron	week 0, 12	Concentration of serum Iron
Pittsburgh Sleep Quality Index (PSQI)	week 0, 12	A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.
Epworth sleepiness Scale (ESS)	week 0, 12	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.
Transferrin Saturation	week 0, 12	Concentration of serum transferrin Saturation
Erythrocyte sedimentation rate	week 0, 12	Concentration of serum erythrocyte sedimentation rate

Trial Locations

Locations (1)

Kuang Tien General Hospital; 🇨🇳 Taichung, Taiwan