AlbuminuriaSODA-POPNCT02020785
Study of Dietary Additive Phosphorus on Proteinuria and Fibroblast Growth Factor-23
A study testing Higher phosphorus period and Lower phosphorus period in people with Albuminuria, run by Geisinger Clinic at 1 site in United States.
Trial summary
Phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Albuminuria
- What is being tested?
- Higher phosphorus period and Lower phosphorus period
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 21 years of age with at least microalbuminuria
Who cannot join
- Estimated glomerular filtration rate <45ml/min/1.73m2, poorly controlled diabetes or hypertension, nephrotic syndrome, hyperparathyroidism, Paget's Disease, multiple myeloma, uncontrolled thyroid disease, chronic antacid use, use of phosphorus binders, phosphorus supplements, or high-dose vitamin D, inability to complete feeding study, investigator discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Prohealth Clinical Research Unit
Baltimore, Maryland, 21207
About this study
Official title: Randomized Cross-over Study Examining the Effects of Phosphorus Additives on Urinary Albumin Excretion and Fibroblast Growth Factor-23
Phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney health. In this study, the investigators will first lower baseline phosphorus intake to about 1000mg/d by educating participants to avoid foods with phosphorus additives. Then, participants will be randomized to a higher phosphorus period (~2gm/d) and a lower phosphorus period (~1gm/d) by providing unaltered, commercially-available food/beverage products with and without phosphorus additives.
The investigators hypothesize that participants will have higher urine albumin excretion and fibroblast growth factor-23 (FGF-23) during the higher phosphorus period compared to the lower phosphorus period.
Read the detailed description
The Study of Dietary Additive Phosphorus on Proteinuria and FGF-23 (SODA-POP) was a single-center, randomized, double-blind, two-period cross-over study that examined the effect of higher vs. lower phosphorus intake for 3 week periods, achieved by addition of commercially available diet beverages and breakfast bars to diet on albuminuria and fibroblast growth factor 23, in adults with presumed early chronic kidney disease (estimated glomerular filtration rate >= 45 ml/min/1.73m2; and urine albumin/creatinine ratio >=17 mg/g for men or >=25 mg/g for women).
- Conditions
- Albuminuria
- Being tested
- Higher phosphorus period, Lower phosphorus period
- Keywords
- proteinuria
- Medical subject headings
- Albuminuria, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher phosphorus periodOther
Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks.
All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives.
Lower phosphorus periodOther
Commercially-available unaltered food/beverage products without phosphorus additives (<10mg/d of phosphorus) will be given for 3 weeks.
All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives.
| Study group | Role | What they receive |
|---|---|---|
| Higher phosphorus period | Active comparator | Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks Receives: Other: Higher phosphorus period |
| Lower phosphorus period | Placebo comparator | Commercially-available unaltered food/beverage products without phosphorus additives (<10mg/d of phosphorus) will be given for 3 weeks Receives: Other: Lower phosphorus period |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Urine Albumin Excretion
Two 24-hour urine collections will be collected during the 3rd week of each period
Measured: 3 weeks
Fibroblast Growth Factor-23 (FGF-23)
Plasma FGF-23 will be measured at the end of each 3 week period in the morning after an overnight fast.
As this is a small pilot study, we will not adjust for multiple comparisons. A p value<0.05 will be considered statistically significant for both outcomes
Measured: 3 weeks
Secondary outcomes (2)
Systolic Blood Pressure
Blood pressure was measured at the end of weeks 1, 2, and 3. At each visit, 3 readings were obtained in the seated position by trained and certified observers after 5 minutes of rest with an Omron HEM-907 device (Omron Healthcare Inc, Bannockburn, Ill) using a standardized protocol. We used the average of all blood pressure measurements at the end of weeks 1, 2, and 3 for each period.
Measured: 2-3 weeks
Diastolic Blood Pressure
Blood pressure measured at the end of weeks 1, 2, and 3. At each visit, 3 readings were obtained in the seated position by trained and certified observers after 5 minutes of rest with an Omron HEM-907 device (Omron Healthcare Inc, Bannockburn, Ill) using a standardized protocol. We used the average of all these readings taken during end of weeks 1, 2, and 3 for each period.
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionSep 2015
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 AlbuminuriaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Alexander Chang, Geisinger Clinic
- Investigators
- Alex R Chang, MD, MS, Principal investigator, Geisinger ClinicLawrence J Appel, MD, MPH, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020785
- Sponsor's protocol ID
- NA_00082089
- Other IDs
- 13CRP16970085, Satellite Dialysis
- Acronym
- SODA-POP
- Status last verified
- Feb 2019
- First submitted
- 19 Dec 2013
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chang A, Batch BC, McGuire HL, Vollmer WM, Svetkey LP, Tyson CC, Sanguankeo A, Anderson C, Houston J, Appel LJ. Association of a reduction in central obesity and phosphorus intake with changes in urinary albumin excretion: the PREMIER study. Am J Kidney Dis. 2013 Nov;62(5):900-7. doi: 10.1053/j.ajkd.2013.04.022. Epub 2013 Jun 28.
PubMed 23810691
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Study Examining the Effects of Phosphorus Additives on Urinary Albumin Excretion and Fibroblast Growth Factor-23
- ClinicalTrials.gov ID
- NCT02020785
- Acronym / sponsor ID
- SODA-POP / NA_00082089
- Conditions
- Albuminuria
- Keywords
- proteinuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Posted 5 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney health. In this study, the investigators will first lower baseline phosphorus intake to about 1000mg/d by educating participants to avoid foods with phosphorus additives. Then, participants will be randomized to a higher phosphorus period (~2gm/d) and a lower phosphorus period (~1gm/d) by providing unaltered, commercially-available food/beverage products with and without phosphorus additives.
The investigators hypothesize that participants will have higher urine albumin excretion and fibroblast growth factor-23 (FGF-23) during the higher phosphorus period compared to the lower phosphorus period.
Detailed description
The Study of Dietary Additive Phosphorus on Proteinuria and FGF-23 (SODA-POP) was a single-center, randomized, double-blind, two-period cross-over study that examined the effect of higher vs. lower phosphorus intake for 3 week periods, achieved by addition of commercially available diet beverages and breakfast bars to diet on albuminuria and fibroblast growth factor 23, in adults with presumed early chronic kidney disease (estimated glomerular filtration rate >= 45 ml/min/1.73m2; and urine albumin/creatinine ratio >=17 mg/g for men or >=25 mg/g for women).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher phosphorus period | Active comparator | Other: Higher phosphorus periodCommercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks |
| Lower phosphorus period | Placebo comparator | Other: Lower phosphorus periodCommercially-available unaltered food/beverage products without phosphorus additives (<10mg/d of phosphorus) will be given for 3 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults at least 21 years of age with at least microalbuminuria
Key exclusion criteria (1 listed)
- Estimated glomerular filtration rate <45ml/min/1.73m2, poorly controlled diabetes or hypertension, nephrotic syndrome, hyperparathyroidism, Paget's Disease, multiple myeloma, uncontrolled thyroid disease, chronic antacid use, use of phosphorus binders, phosphorus supplements, or high-dose vitamin D, inability to complete feeding study, investigator discretion
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 |
|---|---|---|
| Higher phosphorus periodCommercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks. All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives. | Other | Higher phosphorus period |
| Lower phosphorus periodCommercially-available unaltered food/beverage products without phosphorus additives (<10mg/d of phosphorus) will be given for 3 weeks. All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives. | Other | Lower phosphorus period |
Primary outcome
24-hour Urine Albumin Excretion
Time frame: 3 weeks
Two 24-hour urine collections will be collected during the 3rd week of each period
Fibroblast Growth Factor-23 (FGF-23)
Time frame: 3 weeks
Plasma FGF-23 will be measured at the end of each 3 week period in the morning after an overnight fast. As this is a small pilot study, we will not adjust for multiple comparisons. A p value<0.05 will be considered statistically significant for both outcomes
2 secondary outcomes
Systolic Blood Pressure
Time frame: 2-3 weeks
Diastolic Blood Pressure
Time frame: 2-3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23810691Chang A, Batch BC, McGuire HL, Vollmer WM, Svetkey LP, Tyson CC, Sanguankeo A, Anderson C, Houston J, Appel LJ. Association of a reduction in central obesity and phosphorus intake with changes in urinary albumin excretion: the PREMIER study. Am J Kidney Dis. 2013 Nov;62(5):900-7. doi: 10.1053/j.ajkd.2013.04.022. Epub 2013 Jun 28.
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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.
Alex R Chang, MD, MS principal investigator
Geisinger Clinic
Lawrence J Appel, MD, MPH study director
Johns Hopkins 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 Higher phosphorus period and Lower phosphorus period in people with Albuminuria, run by Geisinger Clinic 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 1 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 5 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2019). 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?
24-hour Urine Albumin Excretion (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT02020785, 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 5 Jun 2019.