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

NCT01245517 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-11-22

No results posted yet for this study

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.

Conditions

  • Hyperphosphatemia
  • Malnutrition

Interventions

OTHER

Education

Dietary Phosphorus Education Program

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Shwu-Huey Yang · Taipei Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245517 on ClinicalTrials.gov