- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05860491
Dietary Fiber and Hyperkalemia in Dialysis Patients
May 8, 2023 updated by: Yang Li, Qianfoshan Hospital
The Role of Dietary Fiber on Hyperkalemia in Hemodialysis Patients
To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.
Study Overview
Detailed Description
A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females.
The daily diet was recorded by 3-day dietary recording method.
The daily average dietary nutritional intake and DF intake of MHD patients were calculated by professional software.
Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016).
Of the 100 patients, 37 had hyperkalemia (serum potassium > 5.5 mmol/L) before dialysis.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250014
- Qianfoshan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients undergoing hemodialysis
Description
Inclusion Criteria:
- 18-65 years old; undergoing hemodialysis at least 3months; with a certain level of education; with complete behavioral ability
Exclusion Criteria:
- In the acute phase of acute cardiovascular disease, acute cerebrovascular disease, and acute digestive system disease;Anorexia, long-term malnutrition, or dietary disorders;poor compliance;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with pre-dialysis hyperkalemia
To investigate the dietary fiber intake of hemodialysis patients with pre-dialysis hyperkalemia.
Use a retrospective analysis method.
Analyze the relationship between dietary fiber intake and hyperkalemia.
|
Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia
|
|
patients without pre-dialysis hyperkalemia
To investigate the dietary fiber intake of hemodialysis patients without pre-dialysis hyperkalemia.
Use a retrospective analysis method.
Analyze the relationship between dietary fiber intake and hyperkalemia.
|
Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary fiber intake
Time Frame: 3 day
|
Dietary fiber intake
|
3 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yang Li, Master, Qianfoshan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
May 8, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 16, 2023
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF-hyperkalemia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemolysis
-
Guy's and St Thomas' NHS Foundation TrustUniversity of OxfordNot yet recruitingHemolysis Neonatal
-
Hadassah Medical OrganizationUnknown
-
National Institutes of Health Clinical Center (CC)CompletedIsoagglutinin-Mediated Hemolysis | Probiotic ToxicityUnited States
-
Hospices Civils de LyonCompletedChronic HemolysisFrance
-
Cedars-Sinai Medical CenterWithdrawnAcute Decompensated Heart Failure | Hemolysis IntravascularUnited States
-
Aswan UniversityRecruitingObstetric Hemostasis | Intravascular Hemolysis | Major Obstetric Hemorrhage | Manual Syringing Transfusion | Pneumatic Pressure Bag TransfusionEgypt
-
Radiometer Medical ApSBispebjerg HospitalRecruiting
-
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion...Leiden University Medical CenterCompleted
-
Medical University of GrazJoanneum Research Forschungsgesellschaft mbHCompleted
-
National Heart, Lung, and Blood Institute (NHLBI)Completed
Clinical Trials on dietary fiber
-
Center of Food and Fermentation TechnologiesCompleted
-
University of Missouri-ColumbiaRecruiting
-
BrightseedUniversity of Arkansas; Biofortis Mérieux NutriSciencesActive, not recruiting
-
University of Texas Southwestern Medical CenterCompletedNon-Insulin-Dependent Diabetes Mellitus
-
University of CopenhagenDanish Meat Research InstituteCompleted
-
TsaoTun Psychiatric Center, Department of Health...UnknownSchizophrenia | Central Obesity
-
Ingredion IncorporatedCompleted
-
Ingredion IncorporatedCompletedFocus of the Study is on Gut HealthUnited States
-
Tate & LyleBioFortisCompletedHypercholesterolemiaUnited States