Peritoneal Dialysis ComplicationNCT03569410
The Effect of Natural Protein vs. Protein Supplements on Peritoneal Dialysis Patients
A study testing increased protein intake via natural foods and increase protein intake via protein supplements in people with Peritoneal Dialysis Complication and Hypoalbuminemia, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. A total of 60 patients were enrolled, 16 chose to be in the natural food group and 44 in the supplement group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Dialysis Complication, Hypoalbuminemia, Malnutrition
- What is being tested?
- increased protein intake via natural foods and increase protein intake via protein supplements
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Feb 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Initiation of peritoneal dialysis for at least a one-month time period, with the expectation to stay on peritoneal dialysis for the next 3 months
- Independence with all activities of daily living (especially being able to cook)
Who cannot join
- Age under 18 years
- Expectation of termination of peritoneal dialysis within 3 months of entering the study
- Life expectancy less than three months
- Termination of life or peritoneal dialysis during the study period
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
About this study
Official title: The Effect of Natural Protein vs. Protein Supplements on Peritoneal Dialysis Patients An Open-label Prospective Clinical Trial
This study is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. A total of 60 patients were enrolled, 16 chose to be in the natural food group and 44 in the supplement group. 4 were lost to follow-up in the supplement group leading to an n of 40. Both groups were educated by dietitians on how to increase their protein intake to a goal of 1.4g/kg/day. The groups were followed for 3 months with protein intake calculated according to the patient's food diaries. Patient demographics and characteristics were compared in both groups.
Read the detailed description
This is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. Two treatment groups were established: a natural food group who was instructed by their dietician in how to reach their goal protein intake through purely increasing the consumption of natural foods rich in protein versus a protein supplement group who was instructed by their dietician in how many protein supplements to consume in addition to their natural food intake in order to reach their goal protein intake. To increase compliance, patients were allowed to choose which treatment group they wanted to participate in. Patients, however, were not allowed to change groups during the study.
At the initiation of the study patients were asked to record food diaries so the dietician can calculate their baseline protein intake. Each patient had an assigned dietician who met with the patient monthly. The food diaries were collected during their monthly visits. Patients were also randomly called and asked to give their food intake during the last 24 hours in order to minimize recall bias. Each month the participant's dietician calculated their protein intake deficit and educated the patient on how to increase their protein intake to reach their goal of 1.4g/kg/day. The recommended protein intake for peritoneal dialysis patients is between 1.2 to 1.5 g/kg/day. Therefore, a goal of 1.4g/kg/day was set, which is at the higher end of the goal range in order to ensure an adequately high protein intake.
The patient's serum albumin levels, phosphate levels, kt/v, and total protein intake were recorded at baseline, month 1 (M1), month 2 (M2), and month 3 (M3). Furthermore, all major comorbidities in each patient were recorded and compared. Data was extracted from the electronical medical record system and entered into a password protected file. This data was then analyzed.
- Being tested
- increased protein intake via natural foods, increase protein intake via protein supplements
- Keywords
- peritoneal dialysis, albumin, end stage renal disease
- Medical subject headings
- Hypoalbuminemia, Malnutrition, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increased protein intake via natural foodsBehavioural
Patients had to eat 1.4g/kg/day of natural protein.
increase protein intake via protein supplementsBehavioural
Patients ate enough protein supplements in addition to their regular diet to reach eat 1.4g/kg/day of protein intake.
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Active comparator | The protein supplement group was instructed by their dietician in how many protein supplements to consume in addition to their natural food intake in order to reach their goal protein intake. Receives: Behavioral: increase protein intake via protein supplements |
| Natural Food Group | Experimental | The Natural food group was instructed by their dietician in how much additional protein rich foods to eat in order to reach their goal protein intake. Receives: Behavioral: increased protein intake via natural foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin Levels
serum levels of albumin
Measured: After three months of intervention.
Secondary outcomes (3)
Serum Phosphorus levels
measured monthly
Measured: At Month 0, 1, 2, and 3
Goal protein intake
Via food diaries the total protein intake was calculated
Measured: At Month 0, 1, 2, and 3
Serum albumin levels
throughout the study
Measured: At Month 0, 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startOct 2016
- Primary completionFeb 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label prospective clinical trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Sun, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569410
- Sponsor's protocol ID
- 11101
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeloka TK, Dharmatti G, Jamdade T, Pandit M. Are oral protein supplements helpful in the management of malnutrition in dialysis patients? Indian J Nephrol. 2013 Jan;23(1):1-4. doi: 10.4103/0971-4065.107185.
PubMed 23580797Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W; DGEM (German Society for Nutritional Medicine); Kuhlmann M, Mann H, Horl WH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Adult renal failure. Clin Nutr. 2006 Apr;25(2):295-310. doi: 10.1016/j.clnu.2006.01.023. Epub 2006 May 12.
PubMed 16697495Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation. Am J Kidney Dis. 2000 Jun;35(6 Suppl 2):S17-S104. doi: 10.1053/ajkd.2000.v35.aajkd03517. No abstract available.
PubMed 10895784
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Natural Protein vs. Protein Supplements on Peritoneal Dialysis Patients An Open-label Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03569410
- Acronym / sponsor ID
- 11101
- Keywords
- peritoneal dialysis, albumin, end stage renal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 26 Jun 2018 (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.
This study is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. A total of 60 patients were enrolled, 16 chose to be in the natural food group and 44 in the supplement group. 4 were lost to follow-up in the supplement group leading to an n of 40. Both groups were educated by dietitians on how to increase their protein intake to a goal of 1.4g/kg/day. The groups were followed for 3 months with protein intake calculated according to the patient's food diaries. Patient demographics and characteristics were compared in both groups.
Detailed description
This is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. Two treatment groups were established: a natural food group who was instructed by their dietician in how to reach their goal protein intake through purely increasing the consumption of natural foods rich in protein versus a protein supplement group who was instructed by their dietician in how many protein supplements to consume in addition to their natural food intake in order to reach their goal protein intake. To increase compliance, patients were allowed to choose which treatment group they wanted to participate in. Patients, however, were not allowed to change groups during the study.
At the initiation of the study patients were asked to record food diaries so the dietician can calculate their baseline protein intake. Each patient had an assigned dietician who met with the patient monthly. The food diaries were collected during their monthly visits. Patients were also randomly called and asked to give their food intake during the last 24 hours in order to minimize recall bias. Each month the participant's dietician calculated their protein intake deficit and educated the patient on how to increase their protein intake to reach their goal of 1.4g/kg/day. The recommended protein intake for peritoneal dialysis patients is between 1.2 to 1.5 g/kg/day. Therefore, a goal of 1.4g/kg/day was set, which is at the higher end of the goal range in order to ensure an adequately high protein intake.
The patient's serum albumin levels, phosphate levels, kt/v, and total protein intake were recorded at baseline, month 1 (M1), month 2 (M2), and month 3 (M3). Furthermore, all major comorbidities in each patient were recorded and compared. Data was extracted from the electronical medical record system and entered into a password protected file. This data was then analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label prospective clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Active comparator | Behavioral: increase protein intake via protein supplementsThe protein supplement group was instructed by their dietician in how many protein supplements to consume in addition to their natural food intake in order to reach their goal protein intake. |
| Natural Food Group | Experimental | Behavioral: increased protein intake via natural foodsThe Natural food group was instructed by their dietician in how much additional protein rich foods to eat in order to reach their goal protein intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Initiation of peritoneal dialysis for at least a one-month time period, with the expectation to stay on peritoneal dialysis for the next 3 months
- Independence with all activities of daily living (especially being able to cook)
Key exclusion criteria (5 listed)
- Age under 18 years
- Expectation of termination of peritoneal dialysis within 3 months of entering the study
- Life expectancy less than three months
- Termination of life or peritoneal dialysis during the study period
- Patient refusal
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 |
|---|---|---|
| increased protein intake via natural foodsPatients had to eat 1.4g/kg/day of natural protein. | Behavioural | Natural Food Group |
| increase protein intake via protein supplementsPatients ate enough protein supplements in addition to their regular diet to reach eat 1.4g/kg/day of protein intake. | Behavioural | Supplement Group |
Primary outcome
Serum Albumin Levels
Time frame: After three months of intervention.
serum levels of albumin
3 secondary outcomes
Serum Phosphorus levels
Time frame: At Month 0, 1, 2, and 3
Goal protein intake
Time frame: At Month 0, 1, 2, and 3
Serum albumin levels
Time frame: At Month 0, 1, 2, and 3
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 26 Jun 2018.
- Background: PubMed 23580797Jeloka TK, Dharmatti G, Jamdade T, Pandit M. Are oral protein supplements helpful in the management of malnutrition in dialysis patients? Indian J Nephrol. 2013 Jan;23(1):1-4. doi: 10.4103/0971-4065.107185.
- Background: PubMed 16697495Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W; DGEM (German Society for Nutritional Medicine); Kuhlmann M, Mann H, Horl WH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Adult renal failure. Clin Nutr. 2006 Apr;25(2):295-310. doi: 10.1016/j.clnu.2006.01.023. Epub 2006 May 12.
- Background: PubMed 10895784Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation. Am J Kidney Dis. 2000 Jun;35(6 Suppl 2):S17-S104. doi: 10.1053/ajkd.2000.v35.aajkd03517. No abstract available.
- 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.
Susan Sun, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increased protein intake via natural foods and increase protein intake via protein supplements in people with Peritoneal Dialysis Complication and Hypoalbuminemia, run by Kaiser Permanente at 1 site in United States.
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 3 inclusion and 5 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Levels (time frame: After three months of intervention.). 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 NCT03569410, which also lists 3 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 26 Jun 2018.