Hypertension in Dialysis PatientsPEPPERDISHNCT03990311
Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis
A study testing Sodium Restricted Meals in people with Hypertension in Dialysis Patients and Fluid Overload in Dialysis Patients, run by Tufts Medical Center at 1 site in United States.
Trial summary
This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension in Dialysis Patients, Fluid Overload in Dialysis Patients
- What is being tested?
- Sodium Restricted Meals
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 31 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Treated with outpatient hemodialysis for >60 days
- Mean IDWG over the past 30 days >2 kg
- Speaks and understands English or Chinese
- Patient has a freezer at home with space to store at least 7 prepared meals
- Cognitively intact (able to provide informed consent and answer questionnaires)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.
Read the detailed description
Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.
- Being tested
- Sodium Restricted Meals, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Restricted MealsOther
Also called Dietary Counseling
2 meals prepared with 2 g /day sodium restriction and adhering to dietary recommendations for a hemodialysis patients (phosphate and potassium restricted/ high protein content) 2 meals per day for first month of meal provision period followed by 1 meal per month in the second meal of meal provision period
ControlOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone. Receives: Other: Sodium Restricted Meals |
| Control | Placebo comparator | The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interdialytic Weight Gain throughout Length of Study
A standard measurement taken for HD patients at each dialysis session to see weight gained between sessions
Measured: Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)
Secondary outcomes (1)
Rate of Intradialytic Hypotension Episodes throughout Length of Study
Intradialytic Systolic BP <90 mm Hg
Measured: Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start5 Jun 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990311
- Sponsor's protocol ID
- 999
- Acronym
- PEPPERDISH
- Status last verified
- Jan 2023
- First submitted
- 4 Feb 2019
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis
- ClinicalTrials.gov ID
- NCT03990311
- Acronym / sponsor ID
- PEPPERDISH / 999
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Jun 2019 (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 is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.
Detailed description
Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sodium Restricted MealsThe experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone. |
| Control | Placebo comparator | Other: ControlThe control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18
- Treated with outpatient hemodialysis for >60 days
- Mean IDWG over the past 30 days >2 kg
- Speaks and understands English or Chinese
- Patient has a freezer at home with space to store at least 7 prepared meals
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Sodium Restricted MealsAlso: Dietary Counseling2 meals prepared with 2 g /day sodium restriction and adhering to dietary recommendations for a hemodialysis patients (phosphate and potassium restricted/ high protein content) 2 meals per day for first month of meal provision period followed by 1 meal per month in the second meal of meal provision period | Other | Intervention |
| ControlUsual Care | Other | Control |
Primary outcome
Change in Interdialytic Weight Gain throughout Length of Study
Time frame: Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)
A standard measurement taken for HD patients at each dialysis session to see weight gained between sessions
1 secondary outcome
Rate of Intradialytic Hypotension Episodes throughout Length of Study
Time frame: Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)
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 18 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Restricted Meals in people with Hypertension in Dialysis Patients and Fluid Overload in Dialysis Patients, run by Tufts Medical Center 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 6 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 18 Jan 2023. 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. 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?
Change in Interdialytic Weight Gain throughout Length of Study (time frame: Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.