HyperphosphataemiaNCT07180069
Phosphate Diet Strategies to Lower Blood Phosphate in Dialysis Patients
A study testing diet education in people with Hyperphosphataemia and Phosphorus, run by Kufa University at 1 site in Iraq.
Trial summary
Raised phosphate levels in the blood (hyperphosphatemia) are frequently observed in hemodialysis patients with chronic kidney failure. In addition to increasing the risk of life threatening complications like heart disease, severe bone disorders, and premature mortality, this condition also poses risks to overall… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperphosphataemia, Phosphorus, Diet Therapy
- What is being tested?
- diet education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2024to 1 Jan 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged 18-60 years
- Stage 5 CKD patients on hemodialysis
- Receiving ≥2 weekly dialysis sessions for ≥2 months
- Written informed consent provided
- Ability (patient/caregiver) to read, write, and speak Arabic
Who cannot join
- Age <18 or >60
- Receiving <2 dialysis sessions per week or <2 months duration
- Refusal or inability to provide consent
- Severe mental illness or cognitive impairment
- Acute illness, infection, or hospitalization at enrollment
- Malabsorption conditions or prior GI surgery
- Noncompliance with medication or dialysis regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Strategies for Hyperphosphatemia: A Randomized Controlled Study on the Effectiveness of Phosphate-Specific Interventions in Reducing Serum Phosphate Levels in Hemodialysis Patients in a Dialysis Center
Raised phosphate levels in the blood (hyperphosphatemia) are frequently observed in hemodialysis patients with chronic kidney failure. In addition to increasing the risk of life threatening complications like heart disease, severe bone disorders, and premature mortality, this condition also poses risks to overall health. Managing phosphate levels effectively is one of the central objectives in treating patients on dialysis.
Control of dietary intake, particularly cutting out high phosphate foods, is one of the most effective ways of managing phosphate levels. Dietary restrictions can be challenging for most patients to adhere to, and effective educational tools for assisting them remain unclear.
Read more
This clinical study aims to evaluate the impact of diet-derived education aimed solely at reducing phosphate levels in blood. Patients undergoing hemodialysis at a dialysis center will be randomly assigned to one of two groups. In addition to standard dietary advice, one group will receive targeted phosphate-specific dietary education which includes personalized counseling and aids to encourage selection of low-phosphate foods.
The primary objective is to determine whether participants in the phosphate-specific education group achieve a greater reduction in blood phosphate levels over time as compared to those who receive standard care.
Read the detailed description
this study occurred from October 2024 to January 2025 at the Hemodialysis Unit in the Department of Nephrology at Al-Sader Medical Teaching Hospital. After screening and applying exclusion criteria, a random sample of 200 hemodialysis patients was selected. They were divided equally into two groups (control and intervention), 100 patients in each group. During the trial, five patients were lost: one opted out, two withdrew due to difficulties complying with the prescribed diet, one was removed while awaiting transplantation, and one succumbed to an infection caused by mucormycosis. Thus, 195 volunteers successfully completed the study trial.
A list of all eligible patients who met inclusion criteria was created. Patients were selected by a simple random sampling method. This method involved assigning each eligible patient a unique identification number and then selecting them randomly using a random number generator tool (Excel). A total of 200 patients were chosen to participate. Selected patients were randomly assigned to either the control or intervention group using a fair randomization method to ensure equal distribution. The researcher flipped a fair coin for each patient: if the coin showed the image face, the patient entered the control group; if it showed the writing face, the patient entered the intervention group, which involved receiving dietary counselling according to the study protocol.
Data were collected using two questionnaires: the Medication Adherence Reporting Scale-5 (MARS-5) and a knowledge about phosphate questionnaire . These tools assessed awareness, dietary habits, and phosphate management. They covered demographic data (age, gender, and educational level), dietary behaviors, and chronic conditions history. Baseline phosphorus, PTH, and calcium (Ca) levels were measured. The study evaluated knowledge of phosphate-rich foods, prior education, and ability to identify high phosphate foods. Awareness of phosphate content in dairy products, canned foods, grains, nuts, and processed meats was assessed. Participants also rated their knowledge, their phosphate intake monitoring, and challenges in reducing phosphate intake (lack of knowledge, food availability, and cost). They further reported whether they received dietary guidance and its clarity. Lastly, the study assessed their perceptions of phosphate management, including its importance in preventing complications and confidence in controlling phosphate levels.
Regular follow-ups were conducted during each dialysis session to monitor adherence. Adjustments were made weekly. Serum phosphate and Ca were measured monthly. October 2024 served as baseline, while November, December, and January 2025 were follow-up points. The control group underwent only baseline data collection without intervention. The intervention included counselling and education for a phosphate-specific diet tailored to each patient's food preferences and eating behavior, maintaining a balanced diet with limited phosphorus (800-1000 mg/day), and simple patient-friendly education about phosphate and Ca physiology, risks of hyperphosphatemia, and high phosphate foods.
Brochures handed out to patients included risks of hyperphosphatemia and lists of foods with high and low phosphate content, as well as additives. Another sheet detailed the amount of phosphorus allowed daily or weekly for each type of food, guidance on regulating phosphorus levels, and the importance of adherence to phosphate binders [Appendix 3]. WhatsApp and telephone calls were used to stay connected with patients, address their inquiries, and ensure they received all necessary information. This approach enabled continuous communication, ongoing support, and monitoring of progress and challenges throughout the intervention period.
As part of the program, food preferences and dietary habits were assessed before assigning meal plans. The primary goal was to ensure that daily phosphorus intake remained within 800-1000 mg/day while maintaining balanced nutrition.
- Being tested
- diet education
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet educationOther
Individualized dietary education focused on reducing phosphate intake (food choices, portion control, additives).
| Study group | Role | What they receive |
|---|---|---|
| Standard Dietary Advice" | No intervention | Routine general dietary advice for hemodialysis patients, not phosphate-focused. |
| Phosphate-Specific Dietary Education | Other | Individualized dietary education focused on reducing phosphate intake (food choices, portion control, additives). Receives: Other: diet education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum phosphate concentration measured by standard blood test (mg/dL)
The primary outcome is the change in serum phosphate level from baseline to 12 weeks. Serum phosphate will be measured using venous blood samples and analyzed with an automated chemistry analyzer in the hospital laboratory.
Measured: Baseline and at weeks 4,8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Oct 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphataemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Ali Hamzah, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180069
- Sponsor's protocol ID
- University of kufa
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Strategies for Hyperphosphatemia: A Randomized Controlled Study on the Effectiveness of Phosphate-Specific Interventions in Reducing Serum Phosphate Levels in Hemodialysis Patients in a Dialysis Center
- ClinicalTrials.gov ID
- NCT07180069
- Acronym / sponsor ID
- University of kufa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kufa UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 18 Sep 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.
Raised phosphate levels in the blood (hyperphosphatemia) are frequently observed in hemodialysis patients with chronic kidney failure. In addition to increasing the risk of life threatening complications like heart disease, severe bone disorders, and premature mortality, this condition also poses risks to overall health. Managing phosphate levels effectively is one of the central objectives in treating patients on dialysis.
Control of dietary intake, particularly cutting out high phosphate foods, is one of the most effective ways of managing phosphate levels. Dietary restrictions can be challenging for most patients to adhere to, and effective educational tools for assisting them remain unclear.
This clinical study aims to evaluate the impact of diet-derived education aimed solely at reducing phosphate levels in blood. Patients undergoing hemodialysis at a dialysis center will be randomly assigned to one of two groups. In addition to standard dietary advice, one group will receive targeted phosphate-specific dietary education which includes personalized counseling and aids to encourage selection of low-phosphate foods.
The primary objective is to determine whether participants in the phosphate-specific education group achieve a greater reduction in blood phosphate levels over time as compared to those who receive standard care.
Detailed description
this study occurred from October 2024 to January 2025 at the Hemodialysis Unit in the Department of Nephrology at Al-Sader Medical Teaching Hospital. After screening and applying exclusion criteria, a random sample of 200 hemodialysis patients was selected. They were divided equally into two groups (control and intervention), 100 patients in each group. During the trial, five patients were lost: one opted out, two withdrew due to difficulties complying with the prescribed diet, one was removed while awaiting transplantation, and one succumbed to an infection caused by mucormycosis. Thus, 195 volunteers successfully completed the study trial.
A list of all eligible patients who met inclusion criteria was created. Patients were selected by a simple random sampling method. This method involved assigning each eligible patient a unique identification number and then selecting them randomly using a random number generator tool (Excel). A total of 200 patients were chosen to participate. Selected patients were randomly assigned to either the control or intervention group using a fair randomization method to ensure equal distribution. The researcher flipped a fair coin for each patient: if the coin showed the image face, the patient entered the control group; if it showed the writing face, the patient entered the intervention group, which involved receiving dietary counselling according to the study protocol.
Data were collected using two questionnaires: the Medication Adherence Reporting Scale-5 (MARS-5) and a knowledge about phosphate questionnaire . These tools assessed awareness, dietary habits, and phosphate management. They covered demographic data (age, gender, and educational level), dietary behaviors, and chronic conditions history. Baseline phosphorus, PTH, and calcium (Ca) levels were measured. The study evaluated knowledge of phosphate-rich foods, prior education, and ability to identify high phosphate foods. Awareness of phosphate content in dairy products, canned foods, grains, nuts, and processed meats was assessed. Participants also rated their knowledge, their phosphate intake monitoring, and challenges in reducing phosphate intake (lack of knowledge, food availability, and cost). They further reported whether they received dietary guidance and its clarity. Lastly, the study assessed their perceptions of phosphate management, including its importance in preventing complications and confidence in controlling phosphate levels.
Regular follow-ups were conducted during each dialysis session to monitor adherence. Adjustments were made weekly. Serum phosphate and Ca were measured monthly. October 2024 served as baseline, while November, December, and January 2025 were follow-up points. The control group underwent only baseline data collection without intervention. The intervention included counselling and education for a phosphate-specific diet tailored to each patient's food preferences and eating behavior, maintaining a balanced diet with limited phosphorus (800-1000 mg/day), and simple patient-friendly education about phosphate and Ca physiology, risks of hyperphosphatemia, and high phosphate foods.
Brochures handed out to patients included risks of hyperphosphatemia and lists of foods with high and low phosphate content, as well as additives. Another sheet detailed the amount of phosphorus allowed daily or weekly for each type of food, guidance on regulating phosphorus levels, and the importance of adherence to phosphate binders [Appendix 3]. WhatsApp and telephone calls were used to stay connected with patients, address their inquiries, and ensure they received all necessary information. This approach enabled continuous communication, ongoing support, and monitoring of progress and challenges throughout the intervention period.
As part of the program, food preferences and dietary habits were assessed before assigning meal plans. The primary goal was to ensure that daily phosphorus intake remained within 800-1000 mg/day while maintaining balanced nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dietary Advice" | No intervention | –Routine general dietary advice for hemodialysis patients, not phosphate-focused. |
| Phosphate-Specific Dietary Education | Other | Other: diet educationIndividualized dietary education focused on reducing phosphate intake (food choices, portion control, additives). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females aged 18-60 years
- Stage 5 CKD patients on hemodialysis
- Receiving ≥2 weekly dialysis sessions for ≥2 months
- Written informed consent provided
- Ability (patient/caregiver) to read, write, and speak Arabic
Key exclusion criteria (7 listed)
- Age <18 or >60
- Receiving <2 dialysis sessions per week or <2 months duration
- Refusal or inability to provide consent
- Severe mental illness or cognitive impairment
- Acute illness, infection, or hospitalization at enrollment
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 |
|---|---|---|
| diet educationIndividualized dietary education focused on reducing phosphate intake (food choices, portion control, additives). | Other | Phosphate-Specific Dietary Education |
Primary outcome
Change in serum phosphate concentration measured by standard blood test (mg/dL)
Time frame: Baseline and at weeks 4,8 and week 12
The primary outcome is the change in serum phosphate level from baseline to 12 weeks. Serum phosphate will be measured using venous blood samples and analyzed with an automated chemistry analyzer in the hospital laboratory.
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 18 Sep 2025.
- Individual participant dataSharing planned: Yes
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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 diet education in people with Hyperphosphataemia and Phosphorus, run by Kufa University at 1 site in Iraq.
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 5 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: finished, as of the sponsor's last update on 18 Sep 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 Iraq. 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 phosphate concentration measured by standard blood test (mg/dL) (time frame: Baseline and at weeks 4,8 and week 12). 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 18 Sep 2025.