Phosphorus Improvement Pilot Study
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dietary education
Sponsored by
About this trial
This is an interventional health services research trial for Hyperphosphatemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.
Secondary Outcome Measures
Full Information
NCT ID
NCT00583570
First Posted
December 20, 2007
Last Updated
March 31, 2009
Sponsor
MetroHealth Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00583570
Brief Title
Phosphorus Improvement Pilot Study
Official Title
Phosphorus Improvement Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MetroHealth Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
279 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
dietary education
Intervention Description
dietary education
Primary Outcome Measure Information:
Title
To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwini Sehgal, MD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19211470
Citation
Sullivan C, Sayre SS, Leon JB, Machekano R, Love TE, Porter D, Marbury M, Sehgal AR. Effect of food additives on hyperphosphatemia among patients with end-stage renal disease: a randomized controlled trial. JAMA. 2009 Feb 11;301(6):629-35. doi: 10.1001/jama.2009.96.
Results Reference
result
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Phosphorus Improvement Pilot Study
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