Chronic Kidney DiseaseNCT00764816
Effect of Dietary Protein Source on Phosphaturia, PTH and FGF23 in Patients With CKD 3 and 4
A study testing grain (soy) protein diet and casein (meat) protein diet in people with Chronic Kidney Disease, run by Indiana University at 1 site in United States.
Trial summary
Phosphorus is a substance in the blood that comes from food and is normally cleared from the body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the body as you eat. This leads to problems with bones and blood vessels over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- grain (soy) protein diet and casein (meat) protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2011
- 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 years
- eGFR 20-45 by modified MDRD equation
- protein/creatinine ratio <5
- blood pressure <150/95
- not taking calcium binder or supplements, vitamin D, or phosphate binders
- normal serum phosphorus and calcium corrected for albumin and intact PTH <100pg/ml
- medically stable
- able to give informed consent and come for all visits
Who cannot join
- history of significant liver disease or cirrhosis
- medically unstable
- unable to tolerate diets
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Phosphorus is a substance in the blood that comes from food and is normally cleared from the body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the body as you eat. This leads to problems with bones and blood vessels over time. In this study, we will compare the blood and urine before and after eating one week of a diet with a protein from plants (soy and grains) and before and after another one week of diet with protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts out in the urine, and the changes in blood hormones in response to the diet will be measured at the beginning and end of each week on the two diets.
Read the detailed description
Chronic Kidney Disease-Mineral Bone disorder (CKD-MBD) is a constellation of problems related to alterations in mineral and bone homeostasis that occur in CKD stage 3-5D (estimated GFR 60-15 ml/min). The damaged kidney is unable to fully excrete a phosphorus load, leading to a compensatory secondary hyperparathyroidism to attempt to increase urinary phosphorus excretion in order to maintain serum phosphorus in the normal range. Eventually this compensation of elevated PTH becomes pathologic and leads to abnormalities in biochemistries, bone and vascular disease, all of which are associated with morbidity and mortality in patients with CKD. Prevention of these complications is key to improved patient outcomes. Unfortunately, this normal or high normal phosphorus does not reflect the "behind the scenes" appropriate and inappropriate compensation. The use of medication to bind phosphorus from food (phosphate binders) may prevent absorption of phosphorus across the intestine and prevent or change the elevations in PTH and other hormones like FGF23. Thus, either urinary excretion of phosphorus, or changes in hormone may be more appropriate end points to evaluate efficacy of phosphate binders than is serum phosphorus.
In healthy individuals, there is variation throughout the day (diurnal) in serum phosphorus and urine phosphorus excretion, but in dialysis patients, this variability appears to be lost. No data exists for patients with stage 3 and 4 (pre-dialysis) CKD. Intestinal phosphorus absorption is also dependent on bioavailability (amount of free phosphorus available to be absorbed), which differs depending on the protein source, as the phosphorus in grain/soy diets is less bioavailable than that from protein from animal/casein protein source. In our animal model of CKD, these differences in bioavailability impact urinary phosphorus excretion and serum levels of FGF-23, but not PTH. As phosphaturia, PTH, and FGF23 may become important end points for future clinical trials, understanding diurnal variability and the relationship to diet in patients with CKD 3 and 4 with normal serum phosphorus levels is critical. We hypothesize that dietary protein source will affect the hormonal response and diurnal phosphorus homeostasis in advanced CKD. To test this hypothesis, we will examine the following specific aims in a population of CKD stage 3 and 4 subjects from the Indiana University Affiliated Nephrology Clinics and determine
- if the dietary protein source affects fasting serum and urinary phosphorus excretion
- if the protein source affects post prandial changes in serum and urinary phosphorus in patients
- if changes in plasma FGF23 and PTH correlate with urinary phosphorus excretion in response to different protein sources.
We will conduct a cross over study to assess blood and urine after one week of a diet that differs only in the source of the protein (and thus the bioavailability of phosphorus).
- Conditions
- Chronic Kidney Disease
- Being tested
- grain (soy) protein diet, casein (meat) protein diet
- Keywords
- Chronic kidney disease, stages 3 and 4, phosphaturia, phosphorus, PTH, FGF23, Dietary protein source
- Medical subject headings
- Renal Insufficiency, Chronic, Hypophosphatemia, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grain (soy) protein dietOther
The patient is to eat a grain (soy) protein diet for 7 days. The food is prepared by a registered dietitian.
casein (meat) protein dietOther
The patient is to eat a casein (meat) protein diet for 7 days. The food is prepared by a registered dietitian.
| Study group | Role | What they receive |
|---|---|---|
| 1 grain (soy) protein diet: | Active comparator | The patient is to eat a grain (soy) protein diet for 7 days. The food is prepared by a registered dietitian. Receives: Other: grain (soy) protein diet |
| 2 casein (meat) protein diet | Active comparator | The patient is to eat a casein (meat) protein diet for 7 days. The food is prepared by a registered dietitian. Receives: Other: casein (meat) protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the dietary protein source affects fasting serum and urinary phosphorus excretion in patients with CKD stages 3 and 4.
Measured: 6 months after baseline
Secondary outcomes (2)
To determine if the protein source affects post prandial changes in serum and urinary phosphorus in patients with CKD stages 3 and 4.
Measured: 6 months from baseline
To determine if changes in plasma FGF23 and PTH correlate with urinary phosphorus excretion in response to different protein sources in patients with CKD stages 3 and 4.
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Sharon M Moe, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764816
- Sponsor's protocol ID
- 0807-03
- Status last verified
- Jun 2011
- First submitted
- 1 Oct 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Moe SM, Zidehsarai MP, Chambers MA, Jackman LA, Radcliffe JS, Trevino LL, Donahue SE, Asplin JR. Vegetarian compared with meat dietary protein source and phosphorus homeostasis in chronic kidney disease. Clin J Am Soc Nephrol. 2011 Feb;6(2):257-64. doi: 10.2215/CJN.05040610. Epub 2010 Dec 23.
PubMed 21183586
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Protein Source on Phosphaturia, PTH and FGF23 in Patients With CKD 3 and 4
- ClinicalTrials.gov ID
- NCT00764816
- Acronym / sponsor ID
- 0807-03
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, stages 3 and 4, phosphaturia, phosphorus, PTH, FGF23, Dietary protein source
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Oct 2008 (estimated)
- 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.
Phosphorus is a substance in the blood that comes from food and is normally cleared from the body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the body as you eat. This leads to problems with bones and blood vessels over time. In this study, we will compare the blood and urine before and after eating one week of a diet with a protein from plants (soy and grains) and before and after another one week of diet with protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts out in the urine, and the changes in blood hormones in response to the diet will be measured at the beginning and end of each week on the two diets.
Detailed description
Chronic Kidney Disease-Mineral Bone disorder (CKD-MBD) is a constellation of problems related to alterations in mineral and bone homeostasis that occur in CKD stage 3-5D (estimated GFR 60-15 ml/min). The damaged kidney is unable to fully excrete a phosphorus load, leading to a compensatory secondary hyperparathyroidism to attempt to increase urinary phosphorus excretion in order to maintain serum phosphorus in the normal range. Eventually this compensation of elevated PTH becomes pathologic and leads to abnormalities in biochemistries, bone and vascular disease, all of which are associated with morbidity and mortality in patients with CKD. Prevention of these complications is key to improved patient outcomes. Unfortunately, this normal or high normal phosphorus does not reflect the "behind the scenes" appropriate and inappropriate compensation. The use of medication to bind phosphorus from food (phosphate binders) may prevent absorption of phosphorus across the intestine and prevent or change the elevations in PTH and other hormones like FGF23. Thus, either urinary excretion of phosphorus, or changes in hormone may be more appropriate end points to evaluate efficacy of phosphate binders than is serum phosphorus.
In healthy individuals, there is variation throughout the day (diurnal) in serum phosphorus and urine phosphorus excretion, but in dialysis patients, this variability appears to be lost. No data exists for patients with stage 3 and 4 (pre-dialysis) CKD. Intestinal phosphorus absorption is also dependent on bioavailability (amount of free phosphorus available to be absorbed), which differs depending on the protein source, as the phosphorus in grain/soy diets is less bioavailable than that from protein from animal/casein protein source. In our animal model of CKD, these differences in bioavailability impact urinary phosphorus excretion and serum levels of FGF-23, but not PTH. As phosphaturia, PTH, and FGF23 may become important end points for future clinical trials, understanding diurnal variability and the relationship to diet in patients with CKD 3 and 4 with normal serum phosphorus levels is critical. We hypothesize that dietary protein source will affect the hormonal response and diurnal phosphorus homeostasis in advanced CKD. To test this hypothesis, we will examine the following specific aims in a population of CKD stage 3 and 4 subjects from the Indiana University Affiliated Nephrology Clinics and determine
- if the dietary protein source affects fasting serum and urinary phosphorus excretion
- if the protein source affects post prandial changes in serum and urinary phosphorus in patients
- if changes in plasma FGF23 and PTH correlate with urinary phosphorus excretion in response to different protein sources.
We will conduct a cross over study to assess blood and urine after one week of a diet that differs only in the source of the protein (and thus the bioavailability of phosphorus).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 grain (soy) protein diet: | Active comparator | Other: grain (soy) protein dietThe patient is to eat a grain (soy) protein diet for 7 days. The food is prepared by a registered dietitian. |
| 2 casein (meat) protein diet | Active comparator | Other: casein (meat) protein dietThe patient is to eat a casein (meat) protein diet for 7 days. The food is prepared by a registered dietitian. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age >18 years
- eGFR 20-45 by modified MDRD equation
- protein/creatinine ratio <5
- blood pressure <150/95
- not taking calcium binder or supplements, vitamin D, or phosphate binders
Key exclusion criteria (3 listed)
- history of significant liver disease or cirrhosis
- medically unstable
- unable to tolerate diets
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 |
|---|---|---|
| grain (soy) protein dietThe patient is to eat a grain (soy) protein diet for 7 days. The food is prepared by a registered dietitian. | Other | 1 grain (soy) protein diet: |
| casein (meat) protein dietThe patient is to eat a casein (meat) protein diet for 7 days. The food is prepared by a registered dietitian. | Other | 2 casein (meat) protein diet |
Primary outcome
To determine if the dietary protein source affects fasting serum and urinary phosphorus excretion in patients with CKD stages 3 and 4.
Time frame: 6 months after baseline
2 secondary outcomes
To determine if the protein source affects post prandial changes in serum and urinary phosphorus in patients with CKD stages 3 and 4.
Time frame: 6 months from baseline
To determine if changes in plasma FGF23 and PTH correlate with urinary phosphorus excretion in response to different protein sources in patients with CKD stages 3 and 4.
Time frame: 6 months from baseline
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 23 Jun 2011.
- Results publication: PubMed 21183586Moe SM, Zidehsarai MP, Chambers MA, Jackman LA, Radcliffe JS, Trevino LL, Donahue SE, Asplin JR. Vegetarian compared with meat dietary protein source and phosphorus homeostasis in chronic kidney disease. Clin J Am Soc Nephrol. 2011 Feb;6(2):257-64. doi: 10.2215/CJN.05040610. Epub 2010 Dec 23.
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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.
Sharon M Moe, MD principal investigator
Indiana 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 grain (soy) protein diet and casein (meat) protein diet in people with Chronic Kidney Disease, run by Indiana 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 8 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 23 Jun 2011. 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?
To determine if the dietary protein source affects fasting serum and urinary phosphorus excretion in patients with CKD stages 3 and 4. (time frame: 6 months after baseline). 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 NCT00764816, 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 23 Jun 2011.