Dietary Therapy in Dialysis Patients

NCT04505462 | Completed

• 1 other identifier: FEMH-IRB-109112-F
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with end-stage kidney disease have hyperphosphatemia and accumulated uremic toxin level due to decreased urine excretion ability. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. The investigators hypothesize that therapeutic diet intervention reverses altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. In this study, the investigators crafted 7-day special healthy diet to illustrate the clinical implications of therapeutic diet for dialysis patients.

Conditions

End Stage Renal Disease on Dialysis

Keywords

Therapeutic diet; Mineral metabolism; Uremic toxins; Inflammation; Immune; End-stage kidney disease

Outcome Measures

Primary Outcomes (1)

• Concentrations of intact fibroblast growth factor 23 (pg/mL)

  Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet

  7 days

Secondary Outcomes (15)

• Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)

  7 days

• Concentrations of phosphate (mg/dL)

  7 days

• Concentrations of calcium (mg/dL)

  7 days

• Concentrations of intact parathyroid hormone (pg/mL)

  7 days

• Concentrations of free indoxyl sulfate (mg/L)

  7 days

Study Arms (2)

Study diet

EXPERIMENTAL

7-day therapeutic diet intervention as experimental group

Other: Therapeutic diet

Usual diet

NO INTERVENTION

7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet

Interventions

Therapeutic diet OTHER

A special healthy diet for dialysis patients

Also known as: Dietary therapy

Study diet

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis, serum intact parathyroid hormone less than 800 pg/mL and good dietary compliance

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Serum albumin level less than 2.5 g/dL
• Hospitalization within the past 4 weeks
• Prebiotics, probiotics, symbiotics or antibiotics use within the past 4 weeks
• History of psychiatric disorders
• Having mental retardation
• Those who dislike of the study meals
• Soft diet requirement
• Vegetarian

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

Related Publications (3)

• Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Yang JY, Chen HY, Pai MF, Lin WY, Hung KY, Chu FY, Tsai SM, Chien KL. Short-Term Effects of Very-Low-Phosphate and Low-Phosphate Diets on Fibroblast Growth Factor 23 in Hemodialysis Patients: A Randomized Crossover Trial. Clin J Am Soc Nephrol. 2019 Oct 7;14(10):1475-1483. doi: 10.2215/CJN.04250419. Epub 2019 Sep 13.

  PMID: 31519550 BACKGROUND

• Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Chen HY, Yang JY, Ko MJ, Pai MF, Tu YK, Hung KY, Chien KL. Effects of lower versus higher phosphate diets on fibroblast growth factor-23 levels in patients with chronic kidney disease: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Nov 1;33(11):1977-1983. doi: 10.1093/ndt/gfy005.

  PMID: 29420827 BACKGROUND

• Tsai WC, Hsu SP, Chiu YL, Wu HY, Luan CC, Yang JY, Pai MF, Lin CJ, Lin WY, Sun WH, Peng YS. Short-Term Effects of a Therapeutic Diet on Biochemical Parameters in Hemodialysis Patients: A Randomized Crossover Trial. J Ren Nutr. 2023 Nov;33(6):731-739. doi: 10.1053/j.jrn.2023.04.003. Epub 2023 Apr 27.

  PMID: 37120127 DERIVED

MeSH Terms

Conditions

Inflammation; Kidney Failure, Chronic

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Wan-Chuan Tsai, M.D., Ph.D.

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians who assess the study outcomes will be masked
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: A randomized, active-controlled trial with cross-over design

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 10, 2020
• Study Start: October 28, 2020
• Primary Completion: December 10, 2020
• Study Completion: March 1, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available after completing the study for 1 year and for 3 years after formal publication.
• Access Criteria: Data will be made available by the corresponding author of the paper upon request by email.

Locations

TW (1)