Dietary Phosphorus Load and Postprandial Serum Phosphate in HD Patients

NCT04845724 | Completed

• 1 other identifier: 16-CRFC-32
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to investigate the acute postprandial effect of a modified versus standard low phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent hemodialysis (HD) patients

Conditions

Hemodialysis

Keywords

Dietary phosphorus; Hyperphosphatemia; Hyperkalaemia; Phytate; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Serum Phosphate

  mmol/l

  Post -prandial period (4 hours)

Secondary Outcomes (1)

• Serum Potassium

  Post -prandial period (4 hours)

Other Outcomes (1)

• Serum intact Parathyroid Hormone

  Post -prandial period (4 hours)

Study Arms (2)

Standard Diet

ACTIVE COMPARATOR

The standard diet was based on the current dialysis diet sheet. The standard diet main meal contained a higher proportion of foods with a higher phosphorus to protein ratio (salmon and dairy), and foods with higher phosphorus bioavailability (cake). The diet was tailored for each participant to provide 1.1g protein/kg ideal body weight. The major differences between the diets were at the main meal.

Other: Standard Diet

Modified Diet

EXPERIMENTAL

The modified diet, representative of the proposed modified phosphorus diet used food of lower phosphorus to protein ratio such as beef and less dairy. Approximately 30% dietary phosphorus in the modified diet came from foods with significant phytate content such as pulses, nuts and whole grains. The modified diet was tailored for each participant to provide 1.1g protein/kg ideal body weight.

Other: Modified Diet

Interventions

Standard Diet OTHER

Also known as: Modified Diet

Standard Diet

Modified Diet OTHER

Modified Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age;
• on dialysis for \> 3 months;
• pre-dialysis serum phosphate \< 2.5 mmol/L and
• serum potassium \< 6.3 mmol/L on most recent routine monthly blood test;
• urinary outputs of \< 200 ml/day by self-report;
• being in their usual state of health

You may not qualify if:

• history of diabetes mellitus
• history of parathyroidectomy
• history of calciphylaxis

Sponsors & Collaborators

• University College Cork: lead

Related Publications (1)

• Byrne F, Gillman B, Palmer B, Kiely M, Eustace J, Kearney P, Davidson F, Shiely F. The effect of dietary phosphorus load and food matrix on postprandial serum phosphate in hemodialysis patients: a pilot study. HRB Open Res. 2021 Nov 10;4:119. doi: 10.12688/hrbopenres.13382.1. eCollection 2021.

  PMID: 35187396 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Hyperkalemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• Joseph Eustace, MB

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Catering staff, who were blinded to the identity of the participants, provided meals in random order. Participants were blinded to the initial meal selection until the day of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Joseph Eustace

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: November 26, 2016
• Primary Completion: December 6, 2016
• Study Completion: December 14, 2016
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share