Effect of Restriction of Foods Containing Phosphorus Additives
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
October 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 10, 2015
March 1, 2015
1.9 years
October 9, 2013
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
90 days
Secondary Outcomes (5)
Protein intake at baseline and final.
90 days
Energy intake at baseline and at the final.
90 days
Triceps skinfold at baseline and final.
90 days
Body mass index at baseline and final
90 days
Arm muscle area at baseline and final
90 days
Study Arms (2)
Intervention
ACTIVE COMPARATORRestriction on food containing phosphorus additives.
Control
PLACEBO COMPARATORStandard care.
Interventions
The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.
The control group mantained the usual renal diet oriented prior to the study with a booklet.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of enteral or parenteral therapy
- Presence of physical or cognitive limitation
- Malabsorption diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Ciências Médicas da Santa Casa de São Paulo
São Paulo, São Paulo, 01221-020, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yvoty AS Sens, PHD
Faculdade de Ciências Médicas da Santa Casa de São Paulo
- PRINCIPAL INVESTIGATOR
Margareth LL Fornasari, RD
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD student
Study Record Dates
First Submitted
October 9, 2013
First Posted
October 18, 2013
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
June 1, 2014
Last Updated
March 10, 2015
Record last verified: 2015-03