End-Stage Renal DiseaseNCT02917278
Pilot Study of Nutrition in Maintenance Hemodialysis Patients
A study testing Meals in people with End-Stage Renal Disease and Meals, run by Purdue University at 1 site in United States.
Trial summary
This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Meals, Hemodialysis
- What is being tested?
- Meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- Any race
- Age 18 years or older
- Maintenance hemodialysis patients
Who cannot join
- Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.
- Conditions
- End-Stage Renal Disease, Meals, Hemodialysis
- Being tested
- Meals
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealsDietary supplement
High Protein renal-specific meals
| Study group | Role | What they receive |
|---|---|---|
| Meals | Experimental | High-protein renal-specific meals Receives: Dietary Supplement: Meals |
| Control | No intervention | No Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotensive Event Frequency
frequency of hypotensive events that require intervention during dialysis
Measured: 9 weeks
Secondary outcomes (16)
Mean Arterial Pressure (mm Hg)
Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.
Measured: 9 weeks
Serum Albumin
Measured: 9 weeks
Blood Urea Nitrogen
Measured: 9 weeks
Serum Creatinine
Measured: 9 weeks
Blood Glucose
Measured: 9 weeks
Serum Adjusted Calcium
Measured: 9 weeks
Serum Sodium
Measured: 9 weeks
Serum Phosphate
Measured: 9 weeks
Serum Chloride
Measured: 9 weeks
Serum CO2
Measured: 9 weeks
Serum Pre-albumin
Measured: 9 weeks
Dialysis Absences
Absences out of 25 sessions
Measured: 9 weeks
Interdialytic Weight Gain
Measured: 9 weeks
Vitality Score
Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Measured: 9 weeks
Sleep Problems Index
Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Measured: 9 weeks
Hunger Rating
Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Hill Gallant, Purdue University
- Investigators
- Kathleen M Hill Gallant, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917278
- Sponsor's protocol ID
- 1510016673
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2016
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: De-identified individual participate data is available to other researchers upon reasonable request.
Publications
Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11.
PubMed 30107974
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Nutrition in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02917278
- Acronym / sponsor ID
- 1510016673
- Conditions
- End-Stage Renal Disease, Meals, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meals | Experimental | Dietary Supplement: MealsHigh-protein renal-specific meals |
| Control | No intervention | –No Meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- Any race
- Age 18 years or older
- Maintenance hemodialysis patients
Key exclusion criteria (1 listed)
- Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding
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 |
|---|---|---|
| MealsHigh Protein renal-specific meals | Dietary supplement | Meals |
Primary outcome
Hypotensive Event Frequency
Time frame: 9 weeks
frequency of hypotensive events that require intervention during dialysis
16 secondary outcomes
Mean Arterial Pressure (mm Hg)
Time frame: 9 weeks
Serum Albumin
Time frame: 9 weeks
Blood Urea Nitrogen
Time frame: 9 weeks
Serum Creatinine
Time frame: 9 weeks
Blood Glucose
Time frame: 9 weeks
Serum Adjusted Calcium
Time frame: 9 weeks
Serum Sodium
Time frame: 9 weeks
Serum Phosphate
Time frame: 9 weeks
Serum Chloride
Time frame: 9 weeks
Serum CO2
Time frame: 9 weeks
Serum Pre-albumin
Time frame: 9 weeks
Dialysis Absences
Time frame: 9 weeks
Interdialytic Weight Gain
Time frame: 9 weeks
Vitality Score
Time frame: 9 weeks
Sleep Problems Index
Time frame: 9 weeks
Hunger Rating
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30107974Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11.
- Individual participant dataSharing planned: No. De-identified individual participate data is available to other researchers upon reasonable request.
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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.
Kathleen M Hill Gallant, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meals in people with End-Stage Renal Disease and Meals, run by Purdue University 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 4 inclusion and 1 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 19 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hypotensive Event Frequency (time frame: 9 weeks). 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 NCT02917278, which also lists 1 linked publication.
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 19 Oct 2021.