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Phosphorus Improvement Pilot Study

Primary Purpose

Hyperphosphatemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dietary education
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hyperphosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 20, 2007
    Last Updated
    March 31, 2009
    Sponsor
    MetroHealth Medical Center
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    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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