Chronic Kidney DiseaseNCT05835648
Effect of Dietary Fiber on Non-dialysis Patients With Chronic Kidney Disease
A study testing Nutrasumma in people with Chronic Kidney Disease, run by Qianfoshan Hospital.
Trial summary
The main objective of this study was to investigate the effect of dietary fiber on anemia and glomerular filtration rate in non-dialysis patients with chronic kidney disease. Participants will be randomly divided into a dietary fiber intervention group and a blank control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Nutrasumma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2023to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old;
- Clinically confirmed (history, blood creatinine, kidney B-ultrasound, laboratory examination, etc.) as stage 3-5 chronic kidney disease, endogenous creatinine clearance was < 60ml/min according to Cockcroft-Gault formula;
- Generally in good condition, have a good understanding of their own illness and physical condition, have self-awareness, and can communicate well with others;
- Hemoglobin 100-130g/L;
- In a non-dialysis state.
- Dietary fiber intake <25g/d;
- Voluntarily join the study, understand the significance of the test and the indicators to be measured, and sign the informed consent.
Who cannot join
- Unwilling to join the study; Severe infection: fever, cough and sputum, pharyngeal pain, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L);
- Severe cardiovascular diseases: including chronic cardiac insufficiency grade 3 or above and various arrhythmias;
- Obvious hypoproteinemia: albumin less than 30g/L;
- Corrective measures for anemia (blood transfusion, erythropoietin, HIF-PHI, iron supplement) have been applied in the past 3 months;
- Tumor evidence: certain tumors have been detected or clinical manifestations and tumor markers suggest the possibility of tumor;
- Pregnant women;
- Recent history of heavy blood loss.
About this study
Official title: Effect of Dietary Fiber on Anemia and Glomerular Filtration Rate in Non-dialysis Patients With Chronic Kidney Disease
The main objective of this study was to investigate the effect of dietary fiber on anemia and glomerular filtration rate in non-dialysis patients with chronic kidney disease. Participants will be randomly divided into a dietary fiber intervention group and a blank control group. The patients in the dietary fiber intervention group will have dietary fiber intake survey conducted by dietitians on the basis of basic treatment. Supplemented dietary fiber was given on the basis of daily diet, once a day, 1 piece each time, before meals, and the intervention lasted for 3 months. The blank control group was followed up without intervention. Clinical data, blood, urine and stool samples were collected at the initial diagnosis and at each follow-up site.
- Conditions
- Chronic Kidney Disease
- Being tested
- Nutrasumma
- Keywords
- Dietary fiber, CKD, Anemia, glomerular filtration rate
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutrasummaDietary supplement
On the basis of daily diet, dietary fiber supplement (Nutrasumma) was given once a day, 1 strip each time, before meals, and the intervention lasted for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Dietary fiber intervention group | Experimental | On the basis of daily diet, dietary fiber supplement (Nutrasumma) was given once a day, 1 strip each time, before meals, and the intervention lasted for 3 months. Receives: Dietary Supplement: Nutrasumma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in baseline hemoglobin levels at 9 months
Measured: 9 months
Changes of glomerular filtration rate at baseline at 9 months
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zunsong Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835648
- Sponsor's protocol ID
- CKD-Dietary fiber
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Fiber on Anemia and Glomerular Filtration Rate in Non-dialysis Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05835648
- Acronym / sponsor ID
- CKD-Dietary fiber
- Conditions
- Chronic Kidney Disease
- Keywords
- Dietary fiber, CKD, Anemia, glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 28 Apr 2023 (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.
The main objective of this study was to investigate the effect of dietary fiber on anemia and glomerular filtration rate in non-dialysis patients with chronic kidney disease. Participants will be randomly divided into a dietary fiber intervention group and a blank control group. The patients in the dietary fiber intervention group will have dietary fiber intake survey conducted by dietitians on the basis of basic treatment. Supplemented dietary fiber was given on the basis of daily diet, once a day, 1 piece each time, before meals, and the intervention lasted for 3 months. The blank control group was followed up without intervention. Clinical data, blood, urine and stool samples were collected at the initial diagnosis and at each follow-up site.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary fiber intervention group | Experimental | Dietary Supplement: NutrasummaOn the basis of daily diet, dietary fiber supplement (Nutrasumma) was given once a day, 1 strip each time, before meals, and the intervention lasted for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Above 18 years old;
- Clinically confirmed (history, blood creatinine, kidney B-ultrasound, laboratory examination, etc.) as stage 3-5 chronic kidney disease, endogenous creatinine clearance was < 60ml/min according to Cockcroft-Gault formula;
- Generally in good condition, have a good understanding of their own illness and physical condition, have self-awareness, and can communicate well with others;
- Hemoglobin 100-130g/L;
- In a non-dialysis state.
Key exclusion criteria (7 listed)
- Unwilling to join the study; Severe infection: fever, cough and sputum, pharyngeal pain, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L);
- Severe cardiovascular diseases: including chronic cardiac insufficiency grade 3 or above and various arrhythmias;
- Obvious hypoproteinemia: albumin less than 30g/L;
- Corrective measures for anemia (blood transfusion, erythropoietin, HIF-PHI, iron supplement) have been applied in the past 3 months;
- Tumor evidence: certain tumors have been detected or clinical manifestations and tumor markers suggest the possibility of tumor;
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 |
|---|---|---|
| NutrasummaOn the basis of daily diet, dietary fiber supplement (Nutrasumma) was given once a day, 1 strip each time, before meals, and the intervention lasted for 3 months. | Dietary supplement | Dietary fiber intervention group |
Primary outcome
Changes in baseline hemoglobin levels at 9 months
Time frame: 9 months
Changes of glomerular filtration rate at baseline at 9 months
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrasumma in people with Chronic Kidney Disease, run by Qianfoshan Hospital.
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 7 inclusion and 7 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in baseline hemoglobin levels at 9 months (time frame: 9 months). The study lists 2 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 28 Apr 2023.