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Completed

NCT Number: NCT04845724

Dietary Phosphorus Load and Postprandial Serum Phosphate in HD Patients

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Background: Potential dietary strategies for controlling hyperphosphataemia include the use of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on phosphorus to protein ratios and the avoidance of all phosphate additives.

Method: Controlled crossover feeding study in 8 HD patients. On one day, participants were directly observed eating a standard low phosphorous diet and on the other day, a modified low phosphorus diet. The modified diet included beef and less dairy, with a lower phosphorus to protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing phytates which reduces phosphorus bioavailability. Both diets were tailored for each participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting bloods before breakfast, a pre-prandial sample before lunch and samples at one hour intervals for the four hours after the meal, for analysis of phosphate, potassium and intact parathyroid hormone (iPTH).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 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

Exclusion criteria

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

Treatment and study plan

Standard Diet

Other

Other names: Modified Diet

Modified Diet

Other

Primary outcomes

  1. Serum Phosphate

    Time frame: Post -prandial period (4 hours)

    mmol/l

Secondary outcomes

  1. Serum Potassium

    Time frame: Post -prandial period (4 hours)

    mmol/l

Other outcomes

  1. Serum intact Parathyroid Hormone

    Time frame: Post -prandial period (4 hours)

    ng/L

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

The Effect of Dietary Phosphorus Load and Food Matrix on Postprandial Serum Phosphate in Hemodialysis Patients

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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