Phosphorus and Calcium DisordersNCT04019379
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
A study testing High Phosphorus Diet and Low Phosphorus Diet in people with Phosphorus and Calcium Disorders and Chronic Kidney Disease Mineral and Bone Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
- What is being tested?
- High Phosphorus Diet and Low Phosphorus Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 30 Jan 2023
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, ages 30-75 years old, any race or ethnicity
- Moderate chronic kidney disease
- Female subjects must be postmenopausal (>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test
- Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study
- Willing to discontinue nutritional supplements (e.g. vitamin D, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study
- Adequate vitamin D status defined as serum 25D > 20 ng/mL
Who cannot join
- Plans to initiate dialysis within 6 months
- Hypercalcemia defined as serum calcium >10.5 mg/dL within past 3 months
- Hyperkalemia defined as serum potassium >5.5 mg/dL within past 3 months
- Hyperphosphatemia defined as serum phosphate >5.5 mg/dL within past 3 months
- Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery
- Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension
- Pregnant or breastfeeding
- Prescribed a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter Ca and P metabolism within past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.
Read the detailed description
The goal of this project is to produce preliminary data on the effects of the commonly prescribed dietary phosphorus restriction on whole-body Calcium (Ca) and Phosphorus (P) balance and kinetics patients with CKD, to support a larger future clinical study. The specific aims are to determine intestinal Ca and P fractional absorption and 2) Ca and P balance and full kinetics, effect sizes variance estimates in patients with CKD on a low Ca diet with high P diet versus dietary P restriction. The hypothesis is that a high P diet, in the context of a typical low Ca diet, leads to P retention negative Ca balance, and that dietary P restriction modestly reduces P retention but does not negative Ca balance.
The study design is a randomized 2-period cross-over study. All outpatient and inpatient visits place at the Indiana CTSI Clinical Research Center located in IU Health University Hospital in Indianapolis, IN. Subjects will be randomly assigned to controlled diets of either low Ca/high P (LCa/HP) or low (LCa/LP) for a 1-week, outpatient diet equilibration period, followed by 1-week inpatient full balance that includes a 48-hour Ca and P absorption testing protocol. After a 1-3 week washout subjects will crossover to the other diet regimen
- Conditions
- Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
- Being tested
- High Phosphorus Diet, Low Phosphorus Diet
- Keywords
- Whole-body balance, Kinetic modeling, Intestinal absorption
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Phosphorus DietOther
Controlled research diet of high phosphorus (with low calcium)
Low Phosphorus DietOther
Controlled research diet of low phosphorus (with low calcium)
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | High Phos crossover to Low Phos Receives: Other: High Phosphorus Diet; Other: Low Phosphorus Diet |
| Sequence B | Experimental | Low Phos crossover to High Phos Receives: Other: High Phosphorus Diet; Other: Low Phosphorus Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Calcium Absorption
Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations
Measured: 48 hours
Fractional Phosphorus Absorption
Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations
Measured: 48 hours
Calcium Balance
Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed. Values can be negative, zero, or positive.
Measured: 1 week
Phosphorus Balance
Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed. Values can be negative, zero, or positive.
Measured: 1 weeks
Secondary outcomes (3)
Serum Intact Fibroblast Growth Factor 23 (iFGF23)
Determined by enzyme-linked immunoassay (ELISA). Values for each subject are an average of 6 serial measures taken during the 1 week balance period (between Days 1-8)
Measured: Day 1-8
Serum Intact Parathyroid Hormone (iPTH)
Determined by enzyme-linked immunoassay (ELISA). Values for each subject are an average of 6 serial measures taken during the 1 week balance period (between Days 1-8)
Measured: Day 1-8
Serum 1,25-dihydroxyvitamin D (1,25D)
Determined by LC-MS/MS. Values are from Day 1 of the metabolic balance period (following 1 week of acclimation to assigned study diet).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start31 Aug 2020
- Primary completion28 Oct 2020
- Study completion30 Jan 2023
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.
- Other trials for Phosphorus and Calcium DisordersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Kathleen M Hill Gallant, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019379
- Sponsor's protocol ID
- 1809583731
- Status last verified
- May 2024
- First submitted
- 9 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04019379
- Acronym / sponsor ID
- 1809583731
- Conditions
- Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
- Keywords
- Whole-body balance, Kinetic modeling, Intestinal absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Posted 19 Sep 2024
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 develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.
Detailed description
The goal of this project is to produce preliminary data on the effects of the commonly prescribed dietary phosphorus restriction on whole-body Calcium (Ca) and Phosphorus (P) balance and kinetics patients with CKD, to support a larger future clinical study. The specific aims are to determine intestinal Ca and P fractional absorption and 2) Ca and P balance and full kinetics, effect sizes variance estimates in patients with CKD on a low Ca diet with high P diet versus dietary P restriction. The hypothesis is that a high P diet, in the context of a typical low Ca diet, leads to P retention negative Ca balance, and that dietary P restriction modestly reduces P retention but does not negative Ca balance.
The study design is a randomized 2-period cross-over study. All outpatient and inpatient visits place at the Indiana CTSI Clinical Research Center located in IU Health University Hospital in Indianapolis, IN. Subjects will be randomly assigned to controlled diets of either low Ca/high P (LCa/HP) or low (LCa/LP) for a 1-week, outpatient diet equilibration period, followed by 1-week inpatient full balance that includes a 48-hour Ca and P absorption testing protocol. After a 1-3 week washout subjects will crossover to the other diet regimen
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Other: High Phosphorus Diet, Other: Low Phosphorus DietHigh Phos crossover to Low Phos |
| Sequence B | Experimental | Other: High Phosphorus Diet, Other: Low Phosphorus DietLow Phos crossover to High Phos |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women, ages 30-75 years old, any race or ethnicity
- Moderate chronic kidney disease
- Female subjects must be postmenopausal (>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test
- Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study
- Willing to discontinue nutritional supplements (e.g. vitamin D, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study
Key exclusion criteria (8 listed)
- Plans to initiate dialysis within 6 months
- Hypercalcemia defined as serum calcium >10.5 mg/dL within past 3 months
- Hyperkalemia defined as serum potassium >5.5 mg/dL within past 3 months
- Hyperphosphatemia defined as serum phosphate >5.5 mg/dL within past 3 months
- Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery
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 |
|---|---|---|
| High Phosphorus DietControlled research diet of high phosphorus (with low calcium) | Other | Sequence A, Sequence B |
| Low Phosphorus DietControlled research diet of low phosphorus (with low calcium) | Other | Sequence A, Sequence B |
Primary outcome
Fractional Calcium Absorption
Time frame: 48 hours
Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations
Fractional Phosphorus Absorption
Time frame: 48 hours
Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations
Calcium Balance
Time frame: 1 week
Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed. Values can be negative, zero, or positive.
Phosphorus Balance
Time frame: 1 weeks
Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed. Values can be negative, zero, or positive.
3 secondary outcomes
Serum Intact Fibroblast Growth Factor 23 (iFGF23)
Time frame: Day 1-8
Serum Intact Parathyroid Hormone (iPTH)
Time frame: Day 1-8
Serum 1,25-dihydroxyvitamin D (1,25D)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Phosphorus Diet and Low Phosphorus Diet in people with Phosphorus and Calcium Disorders and Chronic Kidney Disease Mineral and Bone Disorder, run by University of Minnesota 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 8 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 Sep 2024. 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 19 Sep 2024). 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?
Fractional Calcium Absorption (time frame: 48 hours). The study lists 4 primary outcomes in all. 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 19 Sep 2024.