- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01147354
Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
31. januar 2012 oppdatert av: Zahra Sohrabi
The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
After screening all of 280 patients under regular HD in Faghihi Hospital Hemodialysis Center, 80 stable patients in the age range of 18-80 years old were found to be eligible for enrollment and gave their informed consent to participate in this trial.
Subjects were excluded if they were prescribed any multivitamins or immunosuppressive drugs or taking antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study or if they had been hospitalized in the previous month, we also excluded the ones who were pregnant or had active infections.
The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients were randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and were followed for 12 weeks.In order to determine the nutritional statuses of all patients, at the baseline, the questions of SGA and MIS questionnaire were read to the patients and completed in person by the main investigator.
The questions of SGA and MIS were also asked by the same person at the end of treatment phase.Before the onset of the treatment and after the end of the treatment phase of the study, 10cc blood samples were taken from each patient.The blood was taken from the patient's arm used for hemodialysis cannula just before the beginning of the hemodialysis procedure.
The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C.
Serum levels of malondialdehyde (MDA), interleukin-6 (IL-6), high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium , phosphate, parathyroid hormone (PTH), albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels were measured in all patients at the baseline and at the end of treatment phase of study.The aim of this study was to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Fars
-
Shiraz, Fars, Iran, den islamske republikken
- Shiraz University of Medical Sciences
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients who were dialyzed three times a week at least for 3 months or more
Exclusion Criteria:
- Patients who took any multivitamins or immunosuppressive drugs within 2 months prior to enrollment in the study
- Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid,omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study
- Patients who were Hospitalized in the previous month
- Patients who had active infections
- Being pregnant
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: experimental group
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
|
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
|
|
Placebo komparator: control group
The patients in this arm took one placebo capsule daily for 12 weeks.
|
The patients in this arm took one placebo capsule daily for 12 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Global Assessment
Tidsramme: 12-weeks
|
changes in nutritional status according to SGA from baseline to end of treatment
|
12-weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
serum albumin
Tidsramme: 12-weeks
|
12-weeks
|
|
hemoglobin
Tidsramme: 12-weeks
|
12-weeks
|
|
serum malondialdehyde
Tidsramme: 12-weeks
|
12-weeks
|
|
serum parathyroid hormone
Tidsramme: 12-weeks
|
12-weeks
|
|
serum interleukin-6
Tidsramme: 12-weeks
|
12-weeks
|
|
serum phosphorus
Tidsramme: 12-weeks
|
12-weeks
|
|
serum high sensitive c-reactive protein
Tidsramme: 12-weeks
|
12-weeks
|
|
serum calcium
Tidsramme: 12-weeks
|
12-weeks
|
|
serum lipoproteins
Tidsramme: 12-weeks
|
12-weeks
|
|
serum ferritin
Tidsramme: 12-weeks
|
12-weeks
|
|
serum homocysteine
Tidsramme: 12-weeks
|
12-weeks
|
|
total iron binding capacity (TIBC)
Tidsramme: 12-weeks
|
12-weeks
|
|
body mass index (BMI)
Tidsramme: 12-weeks
|
12-weeks
|
|
malnutrition-inflammation score (MIS)
Tidsramme: 12-weeks
|
12-weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Mohammad mahdi Sagheb, M.D, Shiraz University of Medical Sciences
- Hovedetterforsker: Zahra Sohrabi, Ph.D, Shiraz University of Medical Sciences
- Hovedetterforsker: Moosa Salehi, Ph.D, Shiraz University of Medical Sciences
- Hovedetterforsker: Maryam Ekramzadeh, Ph.D, Shiraz University of Medical Sciences
- Hovedetterforsker: Mohammad Kazem Fallahzadeh, M.D, Shiraz University of Medical Sciences
- Hovedetterforsker: Maryam Ayatollahi, Ph.D, Shiraz University of Medical Sciences
- Hovedetterforsker: Bita Geramizadeh, M.D, Shiraz University of Medical Sciences
- Hovedetterforsker: Jafar Hassanzadeh, Ph.D, Shiraz University of Medical Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2009
Primær fullføring (Faktiske)
1. juli 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
17. juni 2010
Først innsendt som oppfylte QC-kriteriene
17. juni 2010
Først lagt ut (Anslag)
22. juni 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. februar 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. januar 2012
Sist bekreftet
1. januar 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 88-4747
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