End-stage Renal DiseaseNCT01965379
Effect of Restriction of Foods Containing Phosphorus Additives
A study testing Restriction on food containing phosphorus additives in people with End-stage Renal Disease and Hyperphosphatemia, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and bone disease . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease, Hyperphosphatemia
- What is being tested?
- Restriction on food containing phosphorus additives
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Jun 2014
- 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
- males or female ≥ 18 years of age
- Chronic kidney disease in stage 5, on hemodialysis for at least 6 months
- Serum phosphorus (P) greater than 5.5 mg/dL persistent in 3 previous months
- Preserved cognitive capacity and able to read and write
- Signed informed written consent
Who cannot join
- Use of enteral or parenteral therapy
- Presence of physical or cognitive limitation
- Malabsorption diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Ciências Médicas da Santa Casa de São Paulo
São Paulo, São Paulo, 01221-020
About this study
Official title: Effect of Restriction of Foods Containing Phosphorus Additives on the Phosphatemia of Patients With End-stage Renal Disease.
Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and bone disease .
The serum phosphorus level can be controlled by a combination of factors, such as: reduction of ingestion, reduction of intestinal absorption with chelating agents and increase in elimination by dialysis.
The purpose of this study is to evaluate the effect of dietary intervention consisting of the restriction of industrialized foods with phosphorus additives in chronic kidney disease patients treated with hemodialysis.
Read the detailed description
The consumption of foods which contain phosphorus by patients on hemodialysis should be monitored in order to reflect the current reality, due to the increase in ingestion of industrialized foods rich in phosphorus additives. Data from studies performed in the USA shows a reduction in phosphatemia with nutritional orientation to reduce foods containing additives from restaurants in the region of the study . In another study, also conducted in the USA, the researchers evaluated the phosphorus content and presence of additives in appetizers and side orders served at fast food restaurants in Cleveland. The results showed that of the appetizers, 52% were accepted by the traditional criteria for the renal diet (low content of sodium, potassium and organic or natural phosphorus), but only 16% were also free of phosphorus additives; of the side orders, 23% were accepted by the traditional criteria and 17% were exempt of phosphorus additives. Thus, only a small proportion of appetizers and side orders served at fast food restaurants were compatible with the renal diet. Considering that alimentary phosphorus has an important role in the control of phosphatemia, there is a lack of studies which evaluates the effect of foods containing phosphorus additives on phosphatemia and which, at the same time, evaluated the alimentary ingestion and the nutritional state of the chronic kidney disease patients treated with hemodialysis.
Can the elimination of foods containing phosphorus additives and their substitution for foods without additives reduce phosphatemia without altering the nutritional state of hyperphosphatemic patients on hemodialysis?
- Conditions
- End-stage Renal Disease, Hyperphosphatemia
- Being tested
- Restriction on food containing phosphorus additives, Standard care
- Keywords
- Dialysis, Phosphorus, Diet
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restriction on food containing phosphorus additivesOther
The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.
Standard careOther
The control group mantained the usual renal diet oriented prior to the study with a booklet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Restriction on food containing phosphorus additives. Receives: Other: Restriction on food containing phosphorus additives |
| Control | Placebo comparator | Standard care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
Measured: 90 days
Secondary outcomes (5)
Protein intake at baseline and final.
Measured: 90 days
Energy intake at baseline and at the final.
Measured: 90 days
Triceps skinfold at baseline and final.
Measured: 90 days
Body mass index at baseline and final
Measured: 90 days
Arm muscle area at baseline and final
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margareth Lage Leite de Fornasari, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- Yvoty AS Sens, PHD, Study chair, Faculdade de Ciências Médicas da Santa Casa de São PauloMargareth LL Fornasari, RD, Principal investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965379
- Sponsor's protocol ID
- Fornasari01
- Status last verified
- Mar 2015
- First submitted
- 9 Oct 2013
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Restriction of Foods Containing Phosphorus Additives on the Phosphatemia of Patients With End-stage Renal Disease.
- ClinicalTrials.gov ID
- NCT01965379
- Acronym / sponsor ID
- Fornasari01
- Conditions
- End-stage Renal Disease, Hyperphosphatemia
- Keywords
- Dialysis, Phosphorus, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Oct 2013 (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.
Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and bone disease .
The serum phosphorus level can be controlled by a combination of factors, such as: reduction of ingestion, reduction of intestinal absorption with chelating agents and increase in elimination by dialysis.
The purpose of this study is to evaluate the effect of dietary intervention consisting of the restriction of industrialized foods with phosphorus additives in chronic kidney disease patients treated with hemodialysis.
Detailed description
The consumption of foods which contain phosphorus by patients on hemodialysis should be monitored in order to reflect the current reality, due to the increase in ingestion of industrialized foods rich in phosphorus additives. Data from studies performed in the USA shows a reduction in phosphatemia with nutritional orientation to reduce foods containing additives from restaurants in the region of the study . In another study, also conducted in the USA, the researchers evaluated the phosphorus content and presence of additives in appetizers and side orders served at fast food restaurants in Cleveland. The results showed that of the appetizers, 52% were accepted by the traditional criteria for the renal diet (low content of sodium, potassium and organic or natural phosphorus), but only 16% were also free of phosphorus additives; of the side orders, 23% were accepted by the traditional criteria and 17% were exempt of phosphorus additives. Thus, only a small proportion of appetizers and side orders served at fast food restaurants were compatible with the renal diet. Considering that alimentary phosphorus has an important role in the control of phosphatemia, there is a lack of studies which evaluates the effect of foods containing phosphorus additives on phosphatemia and which, at the same time, evaluated the alimentary ingestion and the nutritional state of the chronic kidney disease patients treated with hemodialysis.
Can the elimination of foods containing phosphorus additives and their substitution for foods without additives reduce phosphatemia without altering the nutritional state of hyperphosphatemic patients on hemodialysis?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Restriction on food containing phosphorus additivesRestriction on food containing phosphorus additives. |
| Control | Placebo comparator | Other: Standard careStandard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- males or female ≥ 18 years of age
- Chronic kidney disease in stage 5, on hemodialysis for at least 6 months
- Serum phosphorus (P) greater than 5.5 mg/dL persistent in 3 previous months
- Preserved cognitive capacity and able to read and write
- Signed informed written consent
Key exclusion criteria (3 listed)
- Use of enteral or parenteral therapy
- Presence of physical or cognitive limitation
- Malabsorption diseases.
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 |
|---|---|---|
| Restriction on food containing phosphorus additivesThe substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study. | Other | Intervention |
| Standard careThe control group mantained the usual renal diet oriented prior to the study with a booklet. | Other | Control |
Primary outcome
Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
Time frame: 90 days
5 secondary outcomes
Protein intake at baseline and final.
Time frame: 90 days
Energy intake at baseline and at the final.
Time frame: 90 days
Triceps skinfold at baseline and final.
Time frame: 90 days
Body mass index at baseline and final
Time frame: 90 days
Arm muscle area at baseline and final
Time frame: 90 days
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 10 Mar 2015.
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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.
Yvoty AS Sens, PHD study chair
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Margareth LL Fornasari, RD principal investigator
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restriction on food containing phosphorus additives in people with End-stage Renal Disease and Hyperphosphatemia, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 5 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 10 Mar 2015. 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 Brazil. 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 the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL) (time frame: 90 days). 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 10 Mar 2015.