- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01245517
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
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.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shwu-Huey Yang, PhD
- Telefonnummer: 6568 886-2-27361661
- E-post: sherry@tmu.edu.tw
Studiesteder
-
-
-
Taipei, Taiwan
- Rekruttering
- Taipei Medical University - WanFang Hospital
-
Ta kontakt med:
- Shwu-Huey Yang
- Telefonnummer: 6568 886-2-27361661
- E-post: sherry@tmu.edu.tw
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Dietary Phosphorus Education Program
|
Dietary Phosphorus Education Program
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc.
Tidsramme: first month
|
first month
|
The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program.
Tidsramme: third month
|
third month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To estimate subjects' protein and calorie intake according to 3-day dietary records.
Tidsramme: sixth month
|
sixth month
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Shwu-Huey Yang, Taipei Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 99053
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