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

NCT01245517 | Unknown DMC

• 1 other identifier: 99053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperphosphatemia; Malnutrition

Keywords

hyperphosphatemia or malnutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• To estimate subjects' protein and calorie intake according to 3-day dietary records.

  sixth month

Study Arms (1)

Dietary Phosphorus Education Program

EXPERIMENTAL

Other: Education

Interventions

Education OTHER

Dietary Phosphorus Education Program

Dietary Phosphorus Education Program

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hyperphosphatemia; Malnutrition

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Shwu-Huey Yang

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shwu-Huey Yang, PhD

CONTACT

886-2-27361661; sherry@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 22, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 22, 2010

Record last verified: 2010-11

Locations

TW (1)