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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01245517
First received: November 17, 2010
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Hyperphosphatemia
Malnutrition
Other: Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc. [ Time Frame: first month ] [ Designated as safety issue: No ]
  • The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program. [ Time Frame: third month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate subjects' protein and calorie intake according to 3-day dietary records. [ Time Frame: sixth month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary Phosphorus Education Program Other: Education
Dietary Phosphorus Education Program

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245517

Contacts
Contact: Shwu-Huey Yang, PhD 886-2-27361661 ext 6568 sherry@tmu.edu.tw

Locations
Taiwan
Taipei Medical University - WanFang Hospital Recruiting
Taipei, Taiwan
Contact: Shwu-Huey Yang    886-2-27361661 ext 6568    sherry@tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Shwu-Huey Yang Taipei Medical University
  More Information

No publications provided

Responsible Party: Shwu-Huey Yang, Taipei Medical University, School of Nutrition and Health Sciences
ClinicalTrials.gov Identifier: NCT01245517     History of Changes
Other Study ID Numbers: 99053
Study First Received: November 17, 2010
Last Updated: November 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
hyperphosphatemia or malnutrition

Additional relevant MeSH terms:
Hyperphosphatemia
Malnutrition
Nutrition Disorders
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014