Chronic Kidney Disease 5DNCT07277530
Nurse-Led Nutritional Education for Moroccan Dialysis Patients
A study testing Nutritional Education Intervention in people with Chronic Kidney Disease 5D and Hyperkalemia, run by HASSAN 1st university at 1 site in Morocco.
Trial summary
Why was this study done? Many dialysis centers in Morocco lack dietitians to provide proper, individualized dietary support to patients. High potassium levels (hyperkalemia) are a major risk factor for heart problems in dialysis patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease 5D, Hyperkalemia, Hemodialysis
- What is being tested?
- Nutritional Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Feb 2025to 30 Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. Participants must have provided written informed consent.
Who cannot join
- Patients who declined to participate; patients who were minors (under 18 years old); and patients with conditions impairing their ability to understand or receive educational content, such as severe hearing loss or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Morocco1 site
Settat Hemodialysis Center,el borouj Hemodialysis Center, Al amal Hemodialysis Center
Settat, Settat, 26000
About this study
Official title: A Nurse-Led Nutritional Education Intervention Reduces Serum Potassium in Moroccan Hemodialysis Patients Lacking Dietitian Support.
Why was this study done? Many dialysis centers in Morocco lack dietitians to provide proper, individualized dietary support to patients. High potassium levels (hyperkalemia) are a major risk factor for heart problems in dialysis patients. This study tested whether a simple nutritional education program, led by a nurse, could help patients better manage their diet and safely reduce their serum potassium levels.
Who participated? Thirty (30) adult patients with end-stage renal disease receiving hemodialysis participated in the study. They were recruited from three public hemodialysis centers in Morocco that did not have permanent dietitians.
Read more
What did participants do? The study was conducted from February to June 2025. Participants received an educational intervention led by a nurse. The sessions covered potassium content in food, fluid intake, thirst management, and physical activity.
What did the study find (Results)? The educational program resulted in a statistically significant reduction in patients' serum potassium levels. The percentage of patients within the ideal potassium range (4 to 5 mmol/L) increased from 36.7% at the start to 46.7% at the end. This demonstrates that a nurse-led program is a practical and beneficial approach to help lower cardiovascular risk in resource-scarce settings.
The study found no significant changes in Quality of Life (QoL) or interdialytic weight gain (IDWG).
Read the detailed description
This is a single-group, pre-post interventional study designed to evaluate the impact of a nurse-led nutritional education program on the management of End-Stage Renal Disease (ESRD) patients undergoing hemodialysis in a resource-limited setting in Morocco. The study enrolled 30 adult patients.
The intervention was conducted over five months (February to June 2025). The program was delivered by a nurse and included face-to-face sessions as well as remote support (WhatsApp). The educational content focused on three main areas:
Dietary management to reduce hyperkalemia (potassium content in food). Fluid restriction and thirst management. Salt restriction and low-impact physical activity. The primary outcome measure was the change in serum potassium levels (Kalemia) from baseline (T0) to post-intervention (T1). Secondary outcomes included changes in interdialytic weight gain (IDWG) and Quality of Life (QoL).
The results demonstrated a statistically significant reduction in patients' serum potassium levels, supporting the practical benefits of the nurse-led program.
- Conditions
- Chronic Kidney Disease 5D, Hyperkalemia, Hemodialysis
- Being tested
- Nutritional Education Intervention
- Keywords
- Hemodialysis, Nurse-Led, Nutritional Education, Hyperkalemia Management, Interdialytic Weight Gain, Quality of Life
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Education InterventionBehavioural
Educational sessions focused on dietary management of potassium and fluid restriction, salt intake, and low-impact physical activity (stretching). The program was delivered by a nurse in the Moroccan dialect via face-to-face and remote (WhatsApp) communication.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Education Intervention | Experimental | This arm represents the single group in this pre-post study. All 30 participants received the educational intervention over five months (Feb-June 2025). The program focused on dietary management of potassium and fluid, salt intake, and physical stretching exercises, delivered by a nurse in the Moroccan dialect. Receives: Behavioral: Nutritional Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Potassium Level
Change in serum potassium concentration measured at baseline (T0) and after the 12-week educational intervention (T1).
Measured: From baseline to 12 weeks after the start of the intervention.
Secondary outcomes (2)
Change in Interdialytic Weight Gain (IDWG)
Change in interdialytic weight gain, calculated as the mean IDWG during the 4 weeks before baseline and the 4 weeks at the end of the 12-week educational intervention
Measured: 4 weeks before baseline and 4 weeks at the end of the 12-week intervention
Change in Quality of Life (QoL) Index Score
Measured using the validated Arabic version of the EuroQol 5 Dimensions (EQ-5D-5L) instrument.
Measured: From baseline to 12 weeks after the start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pre-post experimental investigation. All participants were assigned to the single intervention group and acted as their own controls, with outcomes measured before (T0) and after (T1) the nurse-led nutritional education program. There was no separate control group.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HASSAN 1st university
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277530
- Sponsor's protocol ID
- CERS/UEMF-2025/EC10/02
- Other IDs
- CERS/UEMF-2025/EC10/02
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this article (e.g., serum potassium levels, IDWG, and EQ-5D-5L scores) will be shared. Data will be made available upon request to the Principal Investigator (PI), following the publication of the final article. The data will be de-identified to protect participant privacy. Requests should be justified and may require an institutional agreement.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-Led Nutritional Education Intervention Reduces Serum Potassium in Moroccan Hemodialysis Patients Lacking Dietitian Support.
- ClinicalTrials.gov ID
- NCT07277530
- Acronym / sponsor ID
- CERS/UEMF-2025/EC10/02
- Conditions
- Chronic Kidney Disease 5D, Hyperkalemia, Hemodialysis
- Keywords
- Hemodialysis, Nurse-Led, Nutritional Education, Hyperkalemia Management, Interdialytic Weight Gain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HASSAN 1st universityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 Dec 2025 (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.
Why was this study done? Many dialysis centers in Morocco lack dietitians to provide proper, individualized dietary support to patients. High potassium levels (hyperkalemia) are a major risk factor for heart problems in dialysis patients. This study tested whether a simple nutritional education program, led by a nurse, could help patients better manage their diet and safely reduce their serum potassium levels.
Who participated? Thirty (30) adult patients with end-stage renal disease receiving hemodialysis participated in the study. They were recruited from three public hemodialysis centers in Morocco that did not have permanent dietitians.
What did participants do? The study was conducted from February to June 2025. Participants received an educational intervention led by a nurse. The sessions covered potassium content in food, fluid intake, thirst management, and physical activity.
What did the study find (Results)? The educational program resulted in a statistically significant reduction in patients' serum potassium levels. The percentage of patients within the ideal potassium range (4 to 5 mmol/L) increased from 36.7% at the start to 46.7% at the end. This demonstrates that a nurse-led program is a practical and beneficial approach to help lower cardiovascular risk in resource-scarce settings.
The study found no significant changes in Quality of Life (QoL) or interdialytic weight gain (IDWG).
Detailed description
This is a single-group, pre-post interventional study designed to evaluate the impact of a nurse-led nutritional education program on the management of End-Stage Renal Disease (ESRD) patients undergoing hemodialysis in a resource-limited setting in Morocco. The study enrolled 30 adult patients.
The intervention was conducted over five months (February to June 2025). The program was delivered by a nurse and included face-to-face sessions as well as remote support (WhatsApp). The educational content focused on three main areas:
Dietary management to reduce hyperkalemia (potassium content in food). Fluid restriction and thirst management. Salt restriction and low-impact physical activity. The primary outcome measure was the change in serum potassium levels (Kalemia) from baseline (T0) to post-intervention (T1). Secondary outcomes included changes in interdialytic weight gain (IDWG) and Quality of Life (QoL).
The results demonstrated a statistically significant reduction in patients' serum potassium levels, supporting the practical benefits of the nurse-led program.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pre-post experimental investigation. All participants were assigned to the single intervention group and acted as their own controls, with outcomes measured before (T0) and after (T1) the nurse-led nutritional education program. There was no separate control group.
| Arm | Type | Receives |
|---|---|---|
| Nutritional Education Intervention | Experimental | Behavioral: Nutritional Education InterventionThis arm represents the single group in this pre-post study. All 30 participants received the educational intervention over five months (Feb-June 2025). The program focused on dietary management of potassium and fluid, salt intake, and physical stretching exercises, delivered by a nurse in the Moroccan dialect. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. Participants must have provided written informed consent.
Key exclusion criteria (1 listed)
- Patients who declined to participate; patients who were minors (under 18 years old); and patients with conditions impairing their ability to understand or receive educational content, such as severe hearing loss or cognitive impairment.
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 |
|---|---|---|
| Nutritional Education InterventionEducational sessions focused on dietary management of potassium and fluid restriction, salt intake, and low-impact physical activity (stretching). The program was delivered by a nurse in the Moroccan dialect via face-to-face and remote (WhatsApp) communication. | Behavioural | Nutritional Education Intervention |
Primary outcome
Change in Serum Potassium Level
Time frame: From baseline to 12 weeks after the start of the intervention.
Change in serum potassium concentration measured at baseline (T0) and after the 12-week educational intervention (T1).
2 secondary outcomes
Change in Interdialytic Weight Gain (IDWG)
Time frame: 4 weeks before baseline and 4 weeks at the end of the 12-week intervention
Change in Quality of Life (QoL) Index Score
Time frame: From baseline to 12 weeks after the start of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this article (e.g., serum potassium levels, IDWG, and EQ-5D-5L scores) will be shared. Data will be made available upon request to the Principal Investigator (PI), following the publication of the final article. The data will be de-identified to protect participant privacy. Requests should be justified and may require an institutional agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Education Intervention in people with Chronic Kidney Disease 5D and Hyperkalemia, run by HASSAN 1st university at 1 site in Morocco.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 Morocco. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Serum Potassium Level (time frame: From baseline to 12 weeks after the start of the intervention.). 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 11 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.