NCT07632105

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

May 25, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

ControlNutritional EducationMaintenanceHemodialysis

Outcome Measures

Primary Outcomes (1)

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

    3 weeks

Secondary Outcomes (1)

  • malnutrition inflammation score

    3 weeks

Study Arms (2)

The education group

EXPERIMENTAL

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

Behavioral: The education group

control group

PLACEBO COMPARATOR

The control group will receive standard treatment.

Behavioral: The control group

Interventions

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

The education group

The control group will receive standard treatment.

control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Internal Medicine

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 8, 2026

Study Start

April 30, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 8, 2026

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations