Peritoneal Dialysis PatientsNCT03367000
Protein Supplementation In Dialysis Patients
A study testing Ceprolac and Dietary counseling (DC) in people with Peritoneal Dialysis Patients, run by National University of Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peritoneal Dialysis Patients
- What is being tested?
- Ceprolac and Dietary counseling (DC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 31 Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with high inflammatory diseases, malignancy, cancer
- Vegetarian patients
About this study
Official title: Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients
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.
Read the detailed description
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).
- Conditions
- Peritoneal Dialysis Patients
- Being tested
- Ceprolac, Dietary counseling (DC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeprolacDietary 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.
Dietary counseling (DC)Other
Received standard dietary counseling at baseline and month 6.
| Study group | Role | What they receive |
|---|---|---|
| Ceprolac | Experimental | Received supplementation which added 27.6g protein and 114kcal to daily nutritional intake as well as standard diet counselling for 6 months Receives: Dietary Supplement: Ceprolac |
| Dietary counseling (DC) | Placebo comparator | Received standard diet counselling only for 6 months. Receives: Other: Dietary counseling (DC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum albumin
Biochemistry marker that indicates nutritional status
Measured: 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
Measured: Change from BMI at 6 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Feb 2012
- Primary completion31 Aug 2013
- Study completion31 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open label controlled trial
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tilakavati Karupaiah, National University of Malaysia
- Investigators
- Tilakavati Karupaiah, Principal investigator, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367000
- Sponsor's protocol ID
- FF-274-2012
- Status last verified
- Dec 2017
- First submitted
- 20 Sep 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32390133Sahathevan 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.
PubMed 29779821
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients
- ClinicalTrials.gov ID
- NCT03367000
- Acronym / sponsor ID
- FF-274-2012
- Conditions
- Peritoneal Dialysis Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Aug 2013 (actual)
- Study completion
- 31 Aug 2013 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open label controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ceprolac | Experimental | Dietary Supplement: CeprolacReceived supplementation which added 27.6g protein and 114kcal to daily nutritional intake as well as standard diet counselling for 6 months |
| Dietary counseling (DC) | Placebo comparator | Other: Dietary counseling (DC)Received standard diet counselling only for 6 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with high inflammatory diseases, malignancy, cancer
- Vegetarian patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeprolacThe 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. | Dietary supplement | Ceprolac |
| Dietary counseling (DC)Received standard dietary counseling at baseline and month 6. | Other | Dietary counseling (DC) |
Primary outcome
Serum albumin
Time frame: Change from baseline serum albumin at 6 months of the study
Biochemistry marker that indicates nutritional status
Body mass index (BMI)
Time frame: Change from BMI at 6 months of the study
Index that depicts if one's current weight is ideal for their height
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Derived from this study: PubMed 32390133Mah 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.
- Derived from this study: PubMed 29779821Sahathevan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilakavati Karupaiah principal investigator
Senior Lecturer
Questions about this trial
What is this clinical trial studying?
A study testing Ceprolac and Dietary counseling (DC) in people with Peritoneal Dialysis Patients, run by National University of Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum albumin (time frame: Change from baseline serum albumin at 6 months of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03367000, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.