Hemodialysis ComplicationNCT06284863
Impact Of Nutritional Education Program In Hemodialysis Patients
A study testing Natritional Education Program In Hemodialysis Patients in people with Hemodialysis Complication, run by Assiut University.
Trial summary
The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Natritional Education Program In Hemodialysis Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Apr 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- hemodialysis patients whatever diabetic or hypertensive
- underweight patients
Who cannot join
- patients diagnosed CKD not on hemodialysis treatment
- patients with malignancy
- patients refuse to participate
- patients age over than 60 years or below 18
- patients with malignancy
- patients refuse to participate
About this study
Official title: Impact Of Nutritional Education Program In Hemodialysis Patients Interventional Study, Isis Hospital, Luxor Governorate
The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program
Read the detailed description
The function of kidney is to control many biological mechanism such as fluid , electrolyte
, PH balance , blood pressure , excretion of toxins and waste , vitamin D and hormonal synthesis . Chronic kidney disease is referred to as " The silent killer " because it often goes undiagnosed due to lack of apparent symptoms. Hemodialysis is life saving treatment in ESRD patients and prolongs life expectancy .
Hemodialysis is a process where the patient"s blood is passed through a dialysis venous catheter via a dialysis fluid solution in a hemodialysis machine to be filtered externally then returned to the patient . Hemodialysis therapy is usually associated with large number of morbidities . However, the inception of hemodialysis is linked with a decrease in functional status among elderly.
As many patients undergoing regular hemodialysis treatment suffer from protein-energy wasting which causes the patient to lose one-three kilos of lean body mass per year, losing body mass is associated with reduction of the overall well being and activity of the patient .
This is associated with worsening of the nutritional status and consequently increase hospitalization and mortality among those patients undergoing regular hemodialysis treatment . Many studies recommended to use both physical and nutritional therapy in order to enhance the outcome and experience of patients on hemodialysis .
The aim of the study:
The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life and serum electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program
- Conditions
- Hemodialysis Complication
- Being tested
- Natritional Education Program In Hemodialysis Patients
- Keywords
- nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natritional Education Program In Hemodialysis PatientsDietary supplement
Impact Of Natritional Education Program In Hemodialysis Patients Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| nutrition | Other | The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program Receives: Dietary Supplement: Natritional Education Program In Hemodialysis Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage patients responded to nutritional education program on hemodialysis patients.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Ahmed Ibrahim Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284863
- Sponsor's protocol ID
- 04-2023-200315
- Status last verified
- Feb 2024
- First submitted
- 4 Jul 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- 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
- Impact Of Nutritional Education Program In Hemodialysis Patients Interventional Study, Isis Hospital, Luxor Governorate
- ClinicalTrials.gov ID
- NCT06284863
- Acronym / sponsor ID
- 04-2023-200315
- Conditions
- Hemodialysis Complication
- Keywords
- nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 29 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.
The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program
Detailed description
The function of kidney is to control many biological mechanism such as fluid , electrolyte
, PH balance , blood pressure , excretion of toxins and waste , vitamin D and hormonal synthesis . Chronic kidney disease is referred to as " The silent killer " because it often goes undiagnosed due to lack of apparent symptoms. Hemodialysis is life saving treatment in ESRD patients and prolongs life expectancy .
Hemodialysis is a process where the patient"s blood is passed through a dialysis venous catheter via a dialysis fluid solution in a hemodialysis machine to be filtered externally then returned to the patient . Hemodialysis therapy is usually associated with large number of morbidities . However, the inception of hemodialysis is linked with a decrease in functional status among elderly.
As many patients undergoing regular hemodialysis treatment suffer from protein-energy wasting which causes the patient to lose one-three kilos of lean body mass per year, losing body mass is associated with reduction of the overall well being and activity of the patient .
This is associated with worsening of the nutritional status and consequently increase hospitalization and mortality among those patients undergoing regular hemodialysis treatment . Many studies recommended to use both physical and nutritional therapy in order to enhance the outcome and experience of patients on hemodialysis .
The aim of the study:
The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life and serum electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nutrition | Other | Dietary Supplement: Natritional Education Program In Hemodialysis PatientsThe study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- hemodialysis patients whatever diabetic or hypertensive
- underweight patients
Key exclusion criteria (6 listed)
- patients diagnosed CKD not on hemodialysis treatment
- patients with malignancy
- patients refuse to participate
- patients age over than 60 years or below 18
- patients with malignancy
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 |
|---|---|---|
| Natritional Education Program In Hemodialysis PatientsImpact Of Natritional Education Program In Hemodialysis Patients Interventional Study | Dietary supplement | nutrition |
Primary outcome
The percentage patients responded to nutritional education program on hemodialysis patients.
Time frame: 3 Months
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.
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 Natritional Education Program In Hemodialysis Patients in people with Hemodialysis Complication, run by Assiut University.
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 2 inclusion and 6 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.
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?
The percentage patients responded to nutritional education program on hemodialysis patients. (time frame: 3 Months). 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.