The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
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|ClinicalTrials.gov Identifier: NCT01245517|
Recruitment Status : Unknown
Verified November 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was: Recruiting
First Posted : November 22, 2010
Last Update Posted : November 22, 2010
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperphosphatemia Malnutrition||Other: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||June 2011|
|Experimental: Dietary Phosphorus Education Program||
Dietary Phosphorus Education Program
- The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc. [ Time Frame: first month ]
- The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program. [ Time Frame: third month ]
- To estimate subjects' protein and calorie intake according to 3-day dietary records. [ Time Frame: sixth month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245517
|Contact: Shwu-Huey Yang, PhD||886-2-27361661 ext firstname.lastname@example.org|
|Taipei Medical University - WanFang Hospital||Recruiting|
|Contact: Shwu-Huey Yang 886-2-27361661 ext 6568 email@example.com|
|Principal Investigator:||Shwu-Huey Yang||Taipei Medical University|