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The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient

The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01245517
Enrollment
60
Registered
2010-11-22
Start date
2010-09-30
Completion date
2011-06-30
Last updated
2010-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphosphatemia, Malnutrition

Keywords

hyperphosphatemia or malnutrition

Brief summary

Aim: Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of hemodialysis patients. Inclusion criteria: The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin \< 4.0 mg/dL, or serum phosphate \> 5.0 mg/dL, are eligible for inclusion. Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions. Intervention protocol: At baseline, the investigators collect demography and pre-test KAP questionnaires among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview and record their answers. Dietary Phosphorus Education is a 6-month program and be implemented by dietitians and investigators, including education, nutritional counseling and dietary records monthly. The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and third month were monthly education sessions, each 20 to 30 minutes. There are total 6 sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry data monthly, biochemistry measurements and 3-day dietary records among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview or phone-interview to complete each dietary record. Investigator collect post-test KAP questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in the end of the trial,. If subjects are illiterate then investigators interview subjects and record. This is a 6-months trial and retrospective study to collect anthropometry, biochemical measurements and 3-day dietary records from control subjects monthly.

Interventions

OTHEREducation

Dietary Phosphorus Education Program

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin \< 4.0 mg/dL, or serum phosphate \> 5.0 mg/dL, are eligible for inclusion. Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects

Exclusion criteria

* Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. * We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions

Design outcomes

Primary

MeasureTime frame
The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc.first month
The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program.third month

Secondary

MeasureTime frame
To estimate subjects' protein and calorie intake according to 3-day dietary records.sixth month

Countries

Taiwan

Contacts

Primary ContactShwu-Huey Yang, PhD
sherry@tmu.edu.tw886-2-27361661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026