NCT00583570

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Status
completed

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

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 1, 2009

Status Verified

March 1, 2009

Enrollment Period

9 months

First QC Date

December 20, 2007

Last Update Submit

March 31, 2009

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

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

    3 months

Study Arms (1)

A

EXPERIMENTAL
Behavioral: dietary education

Interventions

dietary educationBEHAVIORAL

dietary education

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 19211470RESULT

  • 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.

    PMID: 36472416DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Ashwini Sehgal, MD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 1, 2009

Record last verified: 2009-03