Protein Supplementation In Dialysis Patients

NCT03367000 | Completed

• 1 other identifier: FF-274-2012
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

The dialysis population has a strikingly high incidence of mortality. The life expectancy of chronic dialysis patients is 20 years less than that of the general population. Approximately 50% of individuals with end stage renal disease (ESRD) die from a cardiovascular (CV) cause with mortality being 15 to 30 times higher than the age-adjusted CV mortality in the general population. There is also a steady increase of patients with diabetes and the older age groups coming into dialysis. The treatment of patients with ESRD aims at prolonging life, achieving good nutritional status and promoting the best possible functioning and quality of life (QOL). Several factors that are beyond adequacy of dialysis predict high mortality in ESRD patients. Associated co-morbidities and malnutrition factors are independently associated and the combined presence of both malnutrition and co-morbidities manifest the worst survival.Therefore this study investigates the efficacy of protein supplementation in improving health status and quality of life among peritoneal dialysis (PD) patients. This research will also generate basic data about significant health markers critical to the health status of PD patients.

Conditions

Peritoneal Dialysis Patients

Outcome Measures

Primary Outcomes (2)

• Serum albumin

  Biochemistry marker that indicates nutritional status

  Change from baseline serum albumin at 6 months of the study

• Body mass index (BMI)

  Index that depicts if one's current weight is ideal for their height

  Change from BMI at 6 months of the study

Study Arms (2)

Ceprolac

EXPERIMENTAL

Received supplementation which added 27.6g protein and 114kcal to daily nutritional intake as well as standard diet counselling for 6 months

Dietary Supplement: Ceprolac

Dietary counseling (DC)

PLACEBO COMPARATOR

Received standard diet counselling only for 6 months.

Other: Dietary counseling (DC)

Interventions

Ceprolac DIETARY_SUPPLEMENT

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.

Ceprolac

Dietary counseling (DC) OTHER

Received standard dietary counseling at baseline and month 6.

Dietary counseling (DC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with high inflammatory diseases, malignancy, cancer
• Vegetarian patients

Sponsors & Collaborators

• National University of Malaysia: lead

Related Publications (2)

• 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.

  PMID: 32390133 DERIVED

• 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.

  PMID: 29779821 DERIVED

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Tilakavati Karupaiah

  Senior Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Randomized, open label controlled trial

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: December 8, 2017
• Study Start: February 1, 2012
• Primary Completion: August 31, 2013
• Study Completion: August 31, 2013
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share