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

NCT05102279 | Unknown DMC

• 1 other identifier: UUC-2021-10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Calculi, Urinary; Dietary Supplements; Urine Specimen Collection

Keywords

Dietary Supplements; Urine Saturation factor; Calculi, Urinary

Outcome Measures

Primary Outcomes (1)

• Subjects complete the trial within 10 days

  Subjects ate all the food during the trial period and collected all specimens

  10 days

Study Arms (2)

Early administration of high-phosphorus diet test group

EXPERIMENTAL

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

Dietary Supplement: Giving subjects different phosphorus diets at different stages of the trial

Early administration of low-phosphorus diet test group

ACTIVE COMPARATOR

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

Dietary Supplement: Giving subjects different phosphorus diets at different stages of the trial

Interventions

Giving subjects different phosphorus diets at different stages of the trial DIETARY_SUPPLEMENT

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

Early administration of high-phosphorus diet test group; Early administration of low-phosphorus diet test group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200001, China

Location

Related Publications (4)

• 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.

  PMID: 22498635 BACKGROUND

• Shadman A, Bastani B. Kidney Calculi: Pathophysiology and as a Systemic Disorder. Iran J Kidney Dis. 2017 May;11(3):180-191.

  PMID: 28575878 BACKGROUND

• 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.

  PMID: 26150027 BACKGROUND

• 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.

  PMID: 32266417 BACKGROUND

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng Ding, PhD

  Division of Nephrology,Shanghai Ninth People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: December 23, 2021
• Primary Completion: July 31, 2024
• Study Completion: December 30, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)