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

NCT06279429 | Recruiting DMC

• 1 other identifier: KTGH11137
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

CKD; Sleep Disorder

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Study Arms (2)

Sideral® Sucrosomial Iron

EXPERIMENTAL

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

Placebo

ACTIVE COMPARATOR

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

Interventions

Sideral® Sucrosomial Iron DIETARY_SUPPLEMENT

Sucrosomial Iron 30mg

Sideral® Sucrosomial Iron

Iron chewable tablet DIETARY_SUPPLEMENT

Iron chewable tablet 100mg

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients taking iron supplements.
• Patients with non-chronic insomnia.
• Patients with alcoholism within one year.
• People with other serious diseases.
• Pregnant women or women who are still breastfeeding.
• Those who are unable to cooperate with the test progress.
• Patients with autoimmune abnormalities (ex. inflammatory bowel disease).
• People with non-iron deficiency anemia (ex. thalassemia).
• Those who are taking sleeping pills or sedatives.

Sponsors & Collaborators

• Kuang Tien General Hospital: lead

Study Sites (1)

Kuang Tien General Hospital

Taichung, 433, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Chun-Pai Yang, MD

  Chief, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Pai Yang, MD

CONTACT

+886-4-2665-1900; neuralyung@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Neurology

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 28, 2024
• Study Start: May 31, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

TW (1)