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Analysis of Urine Composition Saturation and Dietary Intervention in Subjects Without Urinary Calculi

Primary Purpose

Calculi, Urinary, Dietary Supplements, Urine Specimen Collection

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Giving subjects different phosphorus diets at different stages of the trial
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Calculi, Urinary focused on measuring Dietary Supplements, Urine Saturation factor, Calculi, Urinary

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 20-45 years old
  • 18. 5≤Body Mass Index≤ 23. 9
  • Normal oral diet

Exclusion Criteria:

  • People who have had or are suffering from urinary tract stones , or have the following diseases leading to the formation of stones: renal tubular acidosis, gout, hyperuricemia, chronic diarrhea, insulin resistance, hyperparathyroidism, idiopathic hypercalcemia, hypertension, diabetes mellitus
  • CKD-EPI-eGFR<90ml/min1.73m-2)
  • The following drugs are being used: cathartic, aspirin, angiotensin converting enzyme inhibitor,angiotensin II receptor antagonist,diuretic, acid inhibitor, alkali or carbonic anhydrase inhibitor, phosphorus binder, calcium agent and active vitamin D;
  • Previous gastrointestinal diseases or gastrointestinal surgery
  • Application of enteral and parenteral nutrition
  • Complicated with infection, with or without antibiotic treatment
  • Mental patients or unable to cooperate for various reasons

Sites / Locations

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early administration of high-phosphorus diet test group

Early administration of low-phosphorus diet test group

Arm Description

Group A: 1500 mg phosphorus diet was given on day 1-2, 2500 mg phosphorus diet on day 3-5, 1500 mg phosphorus diet on day 6-7 and 500 mg phosphorus diet on day 8-10

Group B: 1500 mg phosphorus diet was given on day 1-2, 500 mg phosphorus diet on day 3-5, 1500 mg phosphorus diet on day 6-7 and 3500 mg phosphorus diet on day 8-10

Outcomes

Primary Outcome Measures

Subjects complete the trial within 10 days
Subjects ate all the food during the trial period and collected all specimens

Secondary Outcome Measures

Full Information

First Posted
October 20, 2021
Last Updated
November 17, 2022
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT05102279
Brief Title
Analysis of Urine Composition Saturation and Dietary Intervention in Subjects Without Urinary Calculi
Official Title
Analysis of Urine Composition Saturation and Dietary Intervention in Subjects Without Urinary Calculi
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Urinary calculi have become a global public health problem, which brings a huge economic burden to society and individuals. The pathogenesis of urinary calculi is not completely clear. Supersaturation of urinary components is a necessary condition for the formation of urinary calculi. The causes of stone formation are closely related to diet, drugs, metabolic disorders, basic diseases, genetic factors, environment and so on. Diet essentially determines the composition of urine, which affects the formation of urinary calculi. The effect of dietary phosphorus intake on stones is not clear. There is a lack of data to support dietary phosphorus as an influencing factor of stone formation. Phosphorus is present in most foods. 24h urine composition analysis is of great value in predicting the occurrence and composition of urinary calculi. However, due to the interaction between urine components, a single urine component can not well predict the occurrence of stones. Therefore, the researchers introduced the relative supersaturation of common stone components in urine to predict the incidence of stones. Therefore, we want to give healthy adults a diet with different phosphorus content for a period of time to clarify the effect of phosphorus in the diet on 24h urine composition level and urine relative supersaturation, so as to further explore the relationship between dietary phosphorus and the incidence of urinary calculi. To provide more clear recommendations for early prevention of urinary calculi, and provide more evidence for clinical decision-making, thereby reducing the incidence rate of urinary calculi.
Detailed Description
*Diet: Ordinary phosphorus diet: phosphorus content 1500mg High-phosphorus diet: Phosphorus content is 2500mg (inorganic phosphorus is added to the ordinary phosphorus diet) Low-phosphorus diet: Phosphorus content 500mg (The protein content and the ratio of plant protein and animal protein are consistent with the other two diets by adding egg protein and adding low-phosphorus whey protein powder. In addition, calcium magnesium tablets and potassium chloride salt are added to achieve the same calcium, magnesium and potassium content as others. The two diets are consistent) There are 2 recipes for each diet, and each recipe guarantees that the energy, protein, fat, carbohydrate, calcium, magnesium, sodium, potassium, oxalic acid content, vegetable protein and animal protein ratio are basically the same: Energy: 2100kcal (30kcal/kg, standard weight 70kg);Protein: 110g;Fat: 55-60g;Carbohydrate: 300g;Calcium: 600-700mg;Magnesium: 350-400mg;Sodium: 4600mg;Potassium: 2500mg Water:Giving subjects 2L of purified water without any minerals every day Specimen We will collect 24h urine and feces for the whole day on the 2nd, 5th, 7th, and 10th days of the experiment, and collected morning blood and random urine on the 3rd, 6th, 8th, and 11th days. Analysis We will use Equil 2 software to calculate the relative supersaturation of urine, and use SPSS software to analysis data

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calculi, Urinary, Dietary Supplements, Urine Specimen Collection
Keywords
Dietary Supplements, Urine Saturation factor, Calculi, Urinary

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants were randomly divided into two groups.A group of participants first received a normal phosphorus diet for 2 days, followed by a low-phosphorus diet for 3 days, then a normal phosphorus diet for 2 days, and a high-phosphorus diet for 3 days.The other group of participants first received a normal phosphorus diet for 2 days, followed by a high phosphorus diet for 3 days, then a normal phosphorus diet for 2 days, and a low phosphorus diet for 3 days.
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early administration of high-phosphorus diet test group
Arm Type
Experimental
Arm Description
Group A: 1500 mg phosphorus diet was given on day 1-2, 2500 mg phosphorus diet on day 3-5, 1500 mg phosphorus diet on day 6-7 and 500 mg phosphorus diet on day 8-10
Arm Title
Early administration of low-phosphorus diet test group
Arm Type
Active Comparator
Arm Description
Group B: 1500 mg phosphorus diet was given on day 1-2, 500 mg phosphorus diet on day 3-5, 1500 mg phosphorus diet on day 6-7 and 3500 mg phosphorus diet on day 8-10
Intervention Type
Dietary Supplement
Intervention Name(s)
Giving subjects different phosphorus diets at different stages of the trial
Intervention Description
Ordinary phosphorus diet: Phosphorus content 1500mg High phosphorus diet: Phosphorus content 2500mg (inorganic phosphorus is added to the ordinary phosphorus diet) Low phosphorus diet: Phosphorus content 500mg (Protein content is achieved through chicken albumen and addition of low-phosphorus whey protein powder) The ratio of plant protein and animal protein is the same as the other two diets. In addition, calcium-magnesium tablets and potassium chloride salt are added to achieve the same calcium, magnesium and potassium content as the other two diets.) There are 2 recipes for each diet. Ensure that the energy, protein, fat, carbohydrate, calcium, magnesium, sodium, potassium, oxalic acid content, vegetable protein and animal protein ratio are basically the same: Energy: 2100kcal (30kcal/kg, standard body weight 70kg) Protein: 110g Fat: 55-60g Carbohydrate: 300g Calcium: 600-700mg Magnesium: 350-400mg Sodium: 4600mg Potassium: 2500mg
Primary Outcome Measure Information:
Title
Subjects complete the trial within 10 days
Description
Subjects ate all the food during the trial period and collected all specimens
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 20-45 years old 18. 5≤Body Mass Index≤ 23. 9 Normal oral diet Exclusion Criteria: People who have had or are suffering from urinary tract stones , or have the following diseases leading to the formation of stones: renal tubular acidosis, gout, hyperuricemia, chronic diarrhea, insulin resistance, hyperparathyroidism, idiopathic hypercalcemia, hypertension, diabetes mellitus CKD-EPI-eGFR<90ml/min1.73m-2) The following drugs are being used: cathartic, aspirin, angiotensin converting enzyme inhibitor,angiotensin II receptor antagonist,diuretic, acid inhibitor, alkali or carbonic anhydrase inhibitor, phosphorus binder, calcium agent and active vitamin D; Previous gastrointestinal diseases or gastrointestinal surgery Application of enteral and parenteral nutrition Complicated with infection, with or without antibiotic treatment Mental patients or unable to cooperate for various reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Ding, PhD
Organizational Affiliation
Division of Nephrology,Shanghai Ninth People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22498635
Citation
Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
Results Reference
background
PubMed Identifier
28575878
Citation
Shadman A, Bastani B. Kidney Calculi: Pathophysiology and as a Systemic Disorder. Iran J Kidney Dis. 2017 May;11(3):180-191.
Results Reference
background
PubMed Identifier
26150027
Citation
Prezioso D, Strazzullo P, Lotti T, Bianchi G, Borghi L, Caione P, Carini M, Caudarella R, Ferraro M, Gambaro G, Gelosa M, Guttilla A, Illiano E, Martino M, Meschi T, Messa P, Miano R, Napodano G, Nouvenne A, Rendina D, Rocco F, Rosa M, Sanseverino R, Salerno A, Spatafora S, Tasca A, Ticinesi A, Travaglini F, Trinchieri A, Vespasiani G, Zattoni F; CLU Working Group. Dietary treatment of urinary risk factors for renal stone formation. A review of CLU Working Group. Arch Ital Urol Androl. 2015 Jul 7;87(2):105-20. doi: 10.4081/aiua.2015.2.105. Erratum In: Arch Ital Urol Androl. 2016 Mar;88(1):76. Ferraro, Manuel [added].
Results Reference
background
PubMed Identifier
32266417
Citation
Peacock M. Phosphate Metabolism in Health and Disease. Calcif Tissue Int. 2021 Jan;108(1):3-15. doi: 10.1007/s00223-020-00686-3. Epub 2020 Apr 7.
Results Reference
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Analysis of Urine Composition Saturation and Dietary Intervention in Subjects Without Urinary Calculi

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