The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
Primary Purpose
Hyperphosphatemia, Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Education
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring hyperphosphatemia or malnutrition
Eligibility Criteria
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
Sites / Locations
- Taipei Medical University - WanFang HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dietary Phosphorus Education Program
Arm Description
Outcomes
Primary Outcome Measures
The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc.
The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program.
Secondary Outcome Measures
To estimate subjects' protein and calorie intake according to 3-day dietary records.
Full Information
NCT ID
NCT01245517
First Posted
November 17, 2010
Last Updated
November 18, 2010
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01245517
Brief Title
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
Official Title
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Malnutrition
Keywords
hyperphosphatemia or malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary Phosphorus Education Program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Dietary Phosphorus Education Program
Primary Outcome Measure Information:
Title
The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc.
Time Frame
first month
Title
The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program.
Time Frame
third month
Secondary Outcome Measure Information:
Title
To estimate subjects' protein and calorie intake according to 3-day dietary records.
Time Frame
sixth month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shwu-Huey Yang, PhD
Phone
886-2-27361661
Ext
6568
Email
sherry@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shwu-Huey Yang
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University - WanFang Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shwu-Huey Yang
Phone
886-2-27361661
Ext
6568
Email
sherry@tmu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
We'll reach out to this number within 24 hrs