Effect of Restriction of Foods Containing Phosphorus Additives
Primary Purpose
End-stage Renal Disease, Hyperphosphatemia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Restriction on food containing phosphorus additives
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for End-stage Renal Disease focused on measuring Dialysis, Phosphorus, Diet
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Use of enteral or parenteral therapy
- Presence of physical or cognitive limitation
- Malabsorption diseases.
Sites / Locations
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Restriction on food containing phosphorus additives.
Standard care.
Outcomes
Primary Outcome Measures
Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
Secondary Outcome Measures
Protein intake at baseline and final.
Energy intake at baseline and at the final.
Triceps skinfold at baseline and final.
Body mass index at baseline and final
Arm muscle area at baseline and final
Full Information
NCT ID
NCT01965379
First Posted
October 9, 2013
Last Updated
March 9, 2015
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01965379
Brief Title
Effect of Restriction of Foods Containing Phosphorus Additives
Official Title
Effect of Restriction of Foods Containing Phosphorus Additives on the Phosphatemia of Patients With End-stage Renal Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 .
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Hyperphosphatemia
Keywords
Dialysis, Phosphorus, Diet
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Restriction on food containing phosphorus additives.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Standard care.
Intervention Type
Other
Intervention Name(s)
Restriction on food containing phosphorus additives
Intervention Description
The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
The control group mantained the usual renal diet oriented prior to the study with a booklet.
Primary Outcome Measure Information:
Title
Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Protein intake at baseline and final.
Time Frame
90 days
Title
Energy intake at baseline and at the final.
Time Frame
90 days
Title
Triceps skinfold at baseline and final.
Time Frame
90 days
Title
Body mass index at baseline and final
Time Frame
90 days
Title
Arm muscle area at baseline and final
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Use of enteral or parenteral therapy
Presence of physical or cognitive limitation
Malabsorption diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvoty AS Sens, PHD
Organizational Affiliation
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Margareth LL Fornasari, RD
Organizational Affiliation
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Ciências Médicas da Santa Casa de São Paulo
City
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
12. IPD Sharing Statement
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Effect of Restriction of Foods Containing Phosphorus Additives
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