Phosphorus Improvement Pilot Study
March 31, 2009 updated by: MetroHealth Medical Center
Specific Aim: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.
Hypothesis: Educating dialysis patients regarding phosphate containing additives will result in improved serum phosphorus levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The amount of phosphorus in the American diet has increased considerably, primarily from phosphorus-containing additives in convenience and ready to eat foods (Calvo 1996).
It is estimated that, depending on individual food choices, additives add as much 1000 mg/day of phosphorus to the diet (Bell).
Phosphorus in additives is almost entirely absorbed while only 60% of naturally occurring phosphorus is absorbed (Uribarri 2003).
Education regarding high phosphorus foods is a key component of hyperphosphatemia management (Ford 2004, Cupisti 2004), but the use of phosphorus additives may make it difficult for patients and dietitians to estimate phosphorus content of foods.
It has been suggested that hyperphosphatemia is a nutritional barrier to preventing renal bone disease and that an intervention focusing on phosphate containing food additives has great potential (Sherman).
Our objective is to determine the effect of an educational intervention regarding phosphate additives on serum phosphorus about 300 chronic hemodialysis patients at Centers for Dialysis Care (CDC) and Fresenius Medical Care (FMC) in Cuyahoga County.
Facilities will be randomized to intervention and control groups.
All dietitians and eligible patients at the intervention facilities will be invited to take part in the intervention.
All dietitians and consenting eligible patients at control facilities will form a usual care group.
Prior to the trial, demographic and medical characteristics, lab data and medications will be collected for the previous three months using a chart abstraction and patient interview form.
Demographic characteristics include age, sex, race, education and insurance status.
Medical characteristics include dialysis dose, binder prescription, vitamin D dosing, cause of renal failure, number of months on dialysis, and major co-morbid conditions.
Lab data will include albumin, calcium, phosphorus, serum bicarbonate, and PTH.
Medication data will include binder prescription and bone medications.
In the first month of the trial study coordinators will meet with intervention and control subjects and assess basic knowledge regarding phosphorus content of foods and label reading.
Intervention subjects will also receive education regarding phosphorus additives and their effect on the phosphorus content of foods, a laminated card listing common phosphorus additives, and a handout about additives in foods from fast food restaurants where they eat.
The subject will be instructed to use the materials when shopping or eating out to avoid phosphorous additives.
During the 2nd month of the trial, study coordinators will contact intervention subjects by phone to reinforce educational materials and answer questions.
Control subjects will be contacted and asked about shopping and eating habits.
During the 3rd month the interviews from month 1 will be repeated for both intervention and control subjects to assess changes in knowledge.
Intervention subjects will also be asked to evaluate the phosphorus additives tool and provide feedback for evaluating the ease of use and utility.
Having a control group that receives attention but not the key intervention (phosphorus containing additives education and tools) will allow us to distinguish the effect of attention from the effect of the intervention.
Chart abstraction data on labs, dialysis dose, binder prescription, and vitamin D dosing will be collected for all three months of the trial.
Study Type
Interventional
Enrollment (Actual)
279
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Most recent phosphorus and mean phosphorus over last 3 months > 5.5 mg/dL
- Age ≥ 18 years
- On chronic hemodialysis ≥ 6 months
- English speaking
Exclusion Criteria:
- Mentally incompetent
- AIDS
- Cancer
- Terminal illness
- Pregnancy
- Nursing home residence
- No telephone access
- In another phosphorus related study
- Unable to identify written words
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
|
dietary education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ashwini Sehgal, MD, MetroHealth Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (Estimate)
December 31, 2007
Study Record Updates
Last Update Posted (Estimate)
April 1, 2009
Last Update Submitted That Met QC Criteria
March 31, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB06-01323
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