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. 2015 Sep 16;2015(9):CD010350. doi: 10.1002/14651858.CD010350.pub2

Sullivan 2009.

Methods
  • Study design: RCT

  • Duration of study: 3 months

Participants
  • Country: USA

  • Setting: multicentre

  • Diagnostic criteria: HD patients

  • Number: treatment group (145); control group (134)

  • Mean age ± SD (years): treatment group (54 ± 13); control group (52 ± 13)

  • Sex (M/F): treatment group (83/62); control group (88/46)

  • Comorbidity: hyperphosphataemia

Interventions Intervention
  • A study coordinator provided approximately 30 minutes of education regarding phosphorus‐containing additives and provided each intervention participant with a small magnifier in a plastic case. The names of common phosphorus‐containing additives were printed on the case. The coordinator instructed participants to avoid purchasing any items whose ingredient lists include phosphorus‐containing additives. A handout that listed specific menu items to be avoided was also given because they contained phosphorus additives. The study coordinator telephoned intervention participants during the second month of the study to reinforce the instructions and to answer any questions.


Control
  • Participants continued to receive care from their dietitians and nephrologists. A study coordinator telephoned control participants during the second month of the study

Outcomes
  • Serum phosphorus (mg/dL)

Notes
  • Funding: "supported by grant DK51472 from the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, and by the Leonard C. Rosenberg Renal Research Foundation, Cleveland, Ohio. Role of the Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk a random number generator was used
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome data had similar reasons and balanced in numbers across intervention groups. Multiple imputation was used to account for missing data.
Selective reporting (reporting bias) Low risk The published reports included all expected outcomes that were pre‐specified
Other bias Unclear risk Insufficient information to permit judgement

CKD ‐ chronic kidney disease; CrCl ‐ creatinine clearance; FGF‐23 fibroblast growth factor 23; HD ‐ haemodialysis; M/F ‐ male/female; PTH ‐ parathyroid hormone; RCT ‐ randomised controlled trial; SCr ‐ serum creatinine