HemodialysisNCT04845724
Dietary Phosphorus Load and Postprandial Serum Phosphate in HD Patients
A study testing Standard Diet and Modified Diet in people with Hemodialysis, run by University College Cork.
Trial summary
This study is to investigate the acute postprandial effect of a modified versus standard low phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent hemodialysis (HD) patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Standard Diet and Modified Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2016to 14 Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age;
- on dialysis for > 3 months;
- pre-dialysis serum phosphate < 2.5 mmol/L and
- serum potassium < 6.3 mmol/L on most recent routine monthly blood test;
- urinary outputs of < 200 ml/day by self-report;
- being in their usual state of health
Who cannot join
- history of diabetes mellitus
- history of parathyroidectomy
- history of calciphylaxis
About this study
Official title: The Effect of Dietary Phosphorus Load and Food Matrix on Postprandial Serum Phosphate in Hemodialysis Patients
This study is to investigate the acute postprandial effect of a modified versus standard low phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent hemodialysis (HD) patients
Read the detailed description
Background: Potential dietary strategies for controlling hyperphosphataemia include the use of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on phosphorus to protein ratios and the avoidance of all phosphate additives.
Method: Controlled crossover feeding study in 8 HD patients. On one day, participants were directly observed eating a standard low phosphorous diet and on the other day, a modified low phosphorus diet. The modified diet included beef and less dairy, with a lower phosphorus to protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing phytates which reduces phosphorus bioavailability. Both diets were tailored for each participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting bloods before breakfast, a pre-prandial sample before lunch and samples at one hour intervals for the four hours after the meal, for analysis of phosphate, potassium and intact parathyroid hormone (iPTH).
- Conditions
- Hemodialysis
- Being tested
- Standard Diet, Modified Diet
- Keywords
- Dietary phosphorus, Hyperphosphatemia, Hyperkalaemia, Phytate, Hemodialysis
- Medical subject headings
- Hyperphosphatemia, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard DietOther
Also called Modified Diet
Modified DietOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Diet | Active comparator | The standard diet was based on the current dialysis diet sheet. The standard diet main meal contained a higher proportion of foods with a higher phosphorus to protein ratio (salmon and dairy), and foods with higher phosphorus bioavailability (cake). The diet was tailored for each participant to provide 1.1g protein/kg ideal body weight. The major differences between the diets were at the main meal. Receives: Other: Standard Diet |
| Modified Diet | Experimental | The modified diet, representative of the proposed modified phosphorus diet used food of lower phosphorus to protein ratio such as beef and less dairy. Approximately 30% dietary phosphorus in the modified diet came from foods with significant phytate content such as pulses, nuts and whole grains. The modified diet was tailored for each participant to provide 1.1g protein/kg ideal body weight. Receives: Other: Modified Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Phosphate
mmol/l
Measured: Post -prandial period (4 hours)
Secondary outcomes (1)
Serum Potassium
mmol/l
Measured: Post -prandial period (4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start26 Nov 2016
- Primary completion6 Dec 2016
- Study completion14 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Eustace, University College Cork
- Investigators
- Joseph Eustace, MB, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845724
- Sponsor's protocol ID
- 16-CRFC-32
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We did not get consent for publication of identifiable data, and so as perHrynaszkiewicz et al 2010 anthropometric data, sex, ethnicity and age will not be reported in the raw data. We will report the biochemical data and nutrient intake data which allow the reproduction of the analysis we will present.
Publications
Byrne F, Gillman B, Palmer B, Kiely M, Eustace J, Kearney P, Davidson F, Shiely F. The effect of dietary phosphorus load and food matrix on postprandial serum phosphate in hemodialysis patients: a pilot study. HRB Open Res. 2021 Nov 10;4:119. doi: 10.12688/hrbopenres.13382.1. eCollection 2021.
PubMed 35187396
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Phosphorus Load and Food Matrix on Postprandial Serum Phosphate in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04845724
- Acronym / sponsor ID
- 16-CRFC-32
- Conditions
- Hemodialysis
- Keywords
- Dietary phosphorus, Hyperphosphatemia, Hyperkalaemia, Phytate, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 26 Nov 2016 (actual)
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 15 Apr 2021 (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 to investigate the acute postprandial effect of a modified versus standard low phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent hemodialysis (HD) patients
Detailed description
Background: Potential dietary strategies for controlling hyperphosphataemia include the use of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on phosphorus to protein ratios and the avoidance of all phosphate additives.
Method: Controlled crossover feeding study in 8 HD patients. On one day, participants were directly observed eating a standard low phosphorous diet and on the other day, a modified low phosphorus diet. The modified diet included beef and less dairy, with a lower phosphorus to protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing phytates which reduces phosphorus bioavailability. Both diets were tailored for each participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting bloods before breakfast, a pre-prandial sample before lunch and samples at one hour intervals for the four hours after the meal, for analysis of phosphate, potassium and intact parathyroid hormone (iPTH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Diet | Active comparator | Other: Standard DietThe standard diet was based on the current dialysis diet sheet. The standard diet main meal contained a higher proportion of foods with a higher phosphorus to protein ratio (salmon and dairy), and foods with higher phosphorus bioavailability (cake). The diet was tailored for each participant to provide 1.1g protein/kg ideal body weight. The major differences between the diets were at the main meal. |
| Modified Diet | Experimental | Other: Modified DietThe modified diet, representative of the proposed modified phosphorus diet used food of lower phosphorus to protein ratio such as beef and less dairy. Approximately 30% dietary phosphorus in the modified diet came from foods with significant phytate content such as pulses, nuts and whole grains. The modified diet was tailored for each participant to provide 1.1g protein/kg ideal body weight. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 18 years of age;
- on dialysis for > 3 months;
- pre-dialysis serum phosphate < 2.5 mmol/L and
- serum potassium < 6.3 mmol/L on most recent routine monthly blood test;
- urinary outputs of < 200 ml/day by self-report;
Key exclusion criteria (3 listed)
- history of diabetes mellitus
- history of parathyroidectomy
- history of calciphylaxis
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 |
|---|---|---|
| Standard DietAlso: Modified Diet | Other | Standard Diet |
| Modified Diet | Other | Modified Diet |
Primary outcome
Serum Phosphate
Time frame: Post -prandial period (4 hours)
mmol/l
1 secondary outcome
Serum Potassium
Time frame: Post -prandial period (4 hours)
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 30 Apr 2021.
- Derived from this study: PubMed 35187396Byrne F, Gillman B, Palmer B, Kiely M, Eustace J, Kearney P, Davidson F, Shiely F. The effect of dietary phosphorus load and food matrix on postprandial serum phosphate in hemodialysis patients: a pilot study. HRB Open Res. 2021 Nov 10;4:119. doi: 10.12688/hrbopenres.13382.1. eCollection 2021.
- Individual participant dataSharing planned: No. We did not get consent for publication of identifiable data, and so as perHrynaszkiewicz et al 2010 anthropometric data, sex, ethnicity and age will not be reported in the raw data. We will report the biochemical data and nutrient intake data which allow the reproduction of the analysis we will present.
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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.
Joseph Eustace, MB principal investigator
University College Cork
Questions about this trial
What is this clinical trial studying?
A study testing Standard Diet and Modified Diet in people with Hemodialysis, run by University College Cork.
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 3 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 30 Apr 2021. 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. 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 Phosphate (time frame: Post -prandial period (4 hours)). 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 NCT04845724, 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 30 Apr 2021.