- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03367000
Protein Supplementation In Dialysis Patients
Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study is a randomised, open labeled controlled trial where a total of 74 PD patients (37 supplemented; 37 control) were recruited from government and private settings. Subjects were randomised to either the intervention or control group. The intervention group received hydrolysed whey protein supplement and diet counselling for 6 months while the control group received only diet counselling for 6 months.
Patients who consented were first subjected to a screening for identification of eligible subjects. The screening involved basic anthropometry measures (height, weight, BMI), routine biochemistry result obtained from medical record, assessment of nutritional status and dietary evaluation. About 4ml of pre-dialysis blood was also collected by respective nurses for additional laboratory parameters (hsCRP).
During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline and end of the study (at 6 months) for anthropometry assessment, laboratory results, medical condition, hospitalisations, nutritional status, dietary intake and compliance towards supplementation (intervention group only).
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Aged > 18 years old and ≤70 years old
- Undergone dialysis at least for 6 months.
- Categorised as malnourished based on BMI <24 kg/m² and serum albumin ≤40 g/L criteria
- No incidence of hospitalisation for past 3 months, free of infection/sepsis and have not undergone surgery for past 6 months.
Exclusion Criteria:
- Patients with high inflammatory diseases, malignancy, cancer
- Vegetarian patients
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Ceprolac
Received supplementation which added 27.6g protein and 114kcal to daily nutritional intake as well as standard diet counselling for 6 months
|
The supplement was packed into two ~15g sachets in powder form of a 90-94% whey protein isolate and hydrolysed whey.
The protein powder was dissolved in 75-100ml water at room temperature and was ingested post meal once daily.
|
Placebo-jämförare: Dietary counseling (DC)
Received standard diet counselling only for 6 months.
|
Received standard dietary counseling at baseline and month 6.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Serum albumin
Tidsram: Change from baseline serum albumin at 6 months of the study
|
Biochemistry marker that indicates nutritional status
|
Change from baseline serum albumin at 6 months of the study
|
Body mass index (BMI)
Tidsram: Change from BMI at 6 months of the study
|
Index that depicts if one's current weight is ideal for their height
|
Change from BMI at 6 months of the study
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tilakavati Karupaiah, Senior Lecturer
Publikationer och användbara länkar
Allmänna publikationer
- Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
- Sahathevan S, Se CH, Ng S, Khor BH, Chinna K, Goh BL, Gafor HA, Bavanandan S, Ahmad G, Karupaiah T. Clinical efficacy and feasibility of whey protein isolates supplementation in malnourished peritoneal dialysis patients: A multicenter, parallel, open-label randomized controlled trial. Clin Nutr ESPEN. 2018 Jun;25:68-77. doi: 10.1016/j.clnesp.2018.04.002.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- FF-274-2012
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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