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HyperphosphatemiaNCT00583570

Phosphorus Improvement Pilot Study

A study testing dietary education in people with Hyperphosphatemia, run by MetroHealth Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperphosphatemia
What is being tested?
dietary education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
No sites listed yet
Study dates
May 2007to Feb 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Most recent phosphorus and mean phosphorus over last 3 months > 5.5 mg/dL
  • Age ≥ 18 years
  • On chronic hemodialysis ≥ 6 months
  • English speaking

Who cannot join

  • Mentally incompetent
  • AIDS
  • Cancer
  • Terminal illness
  • Pregnancy
  • Nursing home residence
Show all 9Show fewer
  • No telephone access
  • In another phosphorus related study
  • Unable to identify written words

About this study

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.

Read the 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.

Being tested
dietary education
Medical subject headings
Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietary educationBehavioural

    dietary education

Study groups in NCT00583570
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Behavioral: dietary education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00583570
Sponsor's protocol ID
IRB06-01323
Other IDs
IRB06-01323
Status last verified
Mar 2009
First submitted
20 Dec 2007
Last updated
1 Apr 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19211470
  • Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

    PubMed 36472416

Questions about this trial

What is this clinical trial studying?

A study testing dietary education in people with Hyperphosphatemia, run by MetroHealth Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00583570, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2009.

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