CKDNCT06279429
Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia
A study testing Sideral® Sucrosomial Iron and Iron chewable tablet in people with CKD and Sleep Disorder, run by Kuang Tien General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- CKD, Sleep Disorder
- What is being tested?
- Sideral® Sucrosomial Iron and Iron chewable tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Patients with autoimmune abnormalities (ex. inflammatory bowel disease).
- People with non-iron deficiency anemia (ex. thalassemia).
- Those who are taking sleeping pills or sedatives.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kuang Tien General Hospital
Taichung, 433
Nai-Hwei Wang, MD, 886426885599, fengcheese@gmail.com
Chun-Pai Yang, MD
About this study
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
- Being tested
- Sideral® Sucrosomial Iron, Iron chewable tablet
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sideral® Sucrosomial IronDietary supplement
Sucrosomial Iron 30mg
Iron chewable tabletDietary supplement
Iron chewable tablet 100mg
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Iron chewable tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Measured: 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.
Measured: 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.
Measured: week 0, 12
Hemoglobin
Concentration of serum hemoglobin
Measured: week 0, 12
Ferritin
Concentration of serum ferritin
Measured: week 0, 12
Serum Iron
Concentration of serum Iron
Measured: week 0, 12
Transferrin Saturation
Concentration of serum transferrin Saturation
Measured: week 0, 12
Erythrocyte sedimentation rate
Concentration of serum erythrocyte sedimentation rate
Measured: week 0, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start31 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuang Tien General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-pai Yang, MD, Kuang Tien General Hospital
- Investigators
- Chun-Pai Yang, MD, Principal investigator, Chief, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279429
- Sponsor's protocol ID
- KTGH11137
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT06279429
- Acronym / sponsor ID
- KTGH11137
- Conditions
- CKD, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kuang Tien General HospitalUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sideral® Sucrosomial Iron | Experimental | Dietary Supplement: Sideral® Sucrosomial IronThe 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 | Active comparator | Dietary Supplement: Iron chewable tabletThe 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). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sideral® Sucrosomial IronSucrosomial Iron 30mg | Dietary supplement | Sideral® Sucrosomial Iron |
| Iron chewable tabletIron chewable tablet 100mg | Dietary supplement | Placebo |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: week 0, 12
A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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)
Time frame: 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.
Hemoglobin
Time frame: week 0, 12
Concentration of serum hemoglobin
Ferritin
Time frame: week 0, 12
Concentration of serum ferritin
Serum Iron
Time frame: week 0, 12
Concentration of serum Iron
Transferrin Saturation
Time frame: week 0, 12
Concentration of serum transferrin Saturation
Erythrocyte sedimentation rate
Time frame: week 0, 12
Concentration of serum erythrocyte sedimentation rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Pai Yang, MD principal investigator
Chief, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sideral® Sucrosomial Iron and Iron chewable tablet in people with CKD and Sleep Disorder, run by Kuang Tien General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Pai Yang, MD (+886-4-2665-1900, neuralyung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: week 0, 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.