Phosphate Diet Strategies to Lower Blood Phosphate in Dialysis Patients

NCT07180069 | Completed

• 1 other identifier: University of kufa
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hyperphosphataemia; Phosphorus; Diet Therapy; Chronic Kidney Disease 5D

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at weeks 4,8 and week 12

Study Arms (2)

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).

Other: diet education

Interventions

diet education OTHER

Individualized dietary education focused on reducing phosphate intake (food choices, portion control, additives).

Phosphate-Specific Dietary Education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kufa University: lead

Study Sites (1)

University of kufa

Najaf, 24001, Iraq

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IR (1)