Egg White for Phosphorus Control in Haemodialysis Patients

NCT03236701 | Unknown

• 1 other identifier: 76/17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish included in two meals a week with an amount of egg white containing the same quantity of proteins.

Conditions

Renal Insufficiency, Chronic; Dialysis; Hyperphosphatemia

Keywords

hyperphosphatemia; hemodialysis; dietary treatment; egg white; protein energy wasting

Outcome Measures

Primary Outcomes (1)

• Decrease in serum phosphate levels

  This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia

  Phosphate level will be measured monthly for three months from the beginning of the study

Secondary Outcomes (3)

• Changes in body composition assessed by bioelectrical impedance analysis

  BIA will be performed monthly for three months from the beginning of the study

• Changes in serum albumin concentration

  Serum albumin will be measured monthly for three months from the beginning of the study

• Changes in hemoglobin levels

  hemoglobin level will be measured monthly for three months from the beginning of the study

Study Arms (2)

Control

NO INTERVENTION

usual diet

Intervention

EXPERIMENTAL

egg white instead of meat or fish in two meals twice a week for three months

Other: Egg White replacement

Interventions

Egg White replacement OTHER

Nutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white.

Intervention

Eligibility Criteria

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

You may qualify if:

• thrice weekly 4 h standard bicarbonate HD treatment with an at least 6-month vintage
• stable dialysis dose and modality at least by 3 months
• hyperphosphataemia (serum phosphate ≥5.0 mg/dl) at least by 3 months
• stable dietary intake at least by 3 months
• stable body weight at least by 3 months
• stable biochemical markers at least by 3 months

You may not qualify if:

• diabetes
• liver disease
• malignancy
• previous parathyroidectomy
• psychiatric diseases
• non-collaborative patients

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Napoli, 80131, Italy

Location

Related Publications (1)

• Guida B, Parolisi S, Coco M, Ruoppo T, Veccia R, di Maro M, Trio R, Memoli A, Cataldi M. The impact of a nutritional intervention based on egg white for phosphorus control in hemodialyis patients. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):45-50. doi: 10.1016/j.numecd.2018.09.010. Epub 2018 Sep 28.

  PMID: 30459073 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Physiology

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 2, 2017
• Study Start: June 15, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 15, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)