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HemodialysisNCT07632105

Nutritional Education on Control of Serum Potassium Level in Maintenance Hemodialysis Patients

A study testing The education group in people with Hemodialysis and Potassium Measurement, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aims of the present study are to determine how face-to-face nutrition education about potassium will affect serum Potassium levels and reduce its complications and improve quality of life for Maintenance Hemodialysis patients at Internal Medicine Department, Tanta University Hospitals. Read more about this study

Who is it for?
Ages 20 to 65 years
What is being tested?
The education group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteEgypt
Study dates
30 Apr 2024to 30 Apr 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 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult older than 18 years of both sex.
  • Individuals had been undergoing hemodialysis at least three times a week for more than six months.
  • Individuals have a serum potassium level ≥5.5 mEq/L.
  • Able to provide an informed consent.
  • Willingness to adhere to the study protocol for its entire duration.
  • Absence of any planned medical procedures that might interfere with study participation during the study period.

Who cannot join

  • Individuals who had received education on potassium previously. Patients who took potassium-lowering drugs.
  • Individuals whose serum potassium level was below 5.5 mEq/L during the month before the study.
  • Presence of Cardiovascular complications or any event from multiple co-morbid metabolic diseases like pulmonary edema, congestive heart failure, or coma.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University

    Tanta

Other trials in Egypt

About this study

Official title: Effect of Nutritional Education on Control of Serum Potassium Level in Maintenance Hemodialysis Patients

The aims of the present study are to determine how face-to-face nutrition education about potassium will affect serum Potassium levels and reduce its complications and improve quality of life for Maintenance Hemodialysis patients at Internal Medicine Department, Tanta University Hospitals.

Read the detailed description

Nutrition program on patients with chronic renal failure and receiving dialysis plays an important role in the process of treatment1.The purposes of medical nutrition therapy in dialysis patients are to correct patients' appetite, to relieve or prevent the cardiovascular, cerebrovascular, peripheral vascular complications, to prevent increasing fluid accumulations and to ensure optimum nutrition. In addition, medical nutrition helps to control potassium, sodium, and other electrolytes balance.

Potassium (K+) is the most common cation in the body that plays a role in vital functions such as inter-cellular communication, muscle contraction, displacement of fluids between the body parts, transmission of impulses, and release of hormones. Potassium, which is taken into the human body by diet or by other ways like: drugs (beta-blocking agents, angiotensin II receptor blockers, angiotensin-converting enzyme inhibitors and non-steroidal anti-inflammatory drugs), food additives, nutritional supplements, etc., is removed by the kidneys or intestines4. The amount of potassium excretion in hemodialysis treatment is 10% lower than the normal physiological process. The most practical and safe way to compensate for this decrease is to reduce the amount of potassium taken with diet.

In hemodialysis patients, Hyperkalemia is a life-threatening complication. Serum potassium is frequently monitored and managed to maintain its values between 3.5 and 5.5 mmol/L6. Due to impaired renal excretion, these patients are more prone to developing hyperkalemia, therefore, suffer its consequences that is range from, nausea, fatigue, abdominal cramping, paresthesia, and muscle weakness, to severe hyperkalemia (≥6.5 mmol/L) that can cause alterations in cardiac physiology, leading to chest pain, shortness of breath, and sudden cardiac arrest. Both hypo- and hyperkalemia can cause fatal cardiac arrhythmias.

Therefore, different guidelines suggest that patients should restrict their dietary potassium intake to 2-2.5 g per day. However, the benefits of this practice are entirely theoretical and not supported by randomized controlled trials. The hypothesis that potassium restriction is useful is based on that assumption of different sources of dietary potassium are therapeutically equivalent. These restrictions may limit protein intake, exacerbating malnutrition, inflammation, atherosclerosis and increase mortality among hemodialysis patients. In fact, animal and plant sources of potassium may differ in their potential to contribute to hyperkalemia.

Nutrition educations specific to this situation or nutrients improve individuals' knowledge of the subject and positively affect their adherence with the diet. One of the nutrition educations that should be given to patients receiving hemodialysis should be about the amount of potassium intake with diet. During this, patients should be informed about the importance of nutrition in hemodialysis treatment, the potassium content of foods. effects of some cooking methods on the reduction of the potassium content of foods, and on serum potassium levels.

This study will be carried out to assess the effect of short-term intensive renal nutritional education on the control of serum potassium level. Using the Egyptian Potassium Pyramids, followed by performance of nutritional and anthropometric measurements in maintenance HD patients.

Being tested
The education group, The control group
Keywords
Control, Nutritional Education, Maintenance, Hemodialysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The education groupBehavioural

    The education group will undergo a 12-week nutritional education program

  • The control groupBehavioural

    The control group will receive standard treatment.

Study groups in NCT07632105
Study groupRoleWhat they receive
The education groupExperimentalThe education group will undergo a 12-week nutritional education program
Receives: Behavioral: The education group
control groupPlacebo comparatorThe control group will receive standard treatment.
Receives: Behavioral: The control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutritional status of hemodialysis patients by anthropometric measurements weight (Kg ) , Height (m2), body mass index

    Measured: 3 weeks

Secondary outcomes (1)
  1. malnutrition inflammation score

    The assessment evaluates 10 distinct components. Each component is graded on a scale of 0 (normal) to 3 (severely abnormal)

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start30 Apr 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07632105
Sponsor's protocol ID
36264MS509/2/24
Status last verified
Apr 2024
First submitted
25 May 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It will be available if it needed

Questions about this trial

What is this clinical trial studying?

A study testing The education group in people with Hemodialysis and Potassium Measurement, run by Tanta University at 1 site in Egypt.

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 6 inclusion and 3 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 8 Jun 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?

Nutritional status of hemodialysis patients by anthropometric measurements weight (Kg ) , Height (m2), body mass index (time frame: 3 weeks). 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 8 Jun 2026.

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