Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05862207
Other study ID # Nephrocalcinosis in children
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2023
Est. completion date May 2024

Study information

Verified date June 2023
Source Sohag University
Contact Menna Saad Mohamed, master degree
Phone 0158112682
Email menasaad@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To study prevalence, risk factors, possible etiologies, clinical presentation and outcome of nephrocalcinosis in children at Sohag University Hospital.


Description:

Nephrocalcinosis (NC) is characterized by deposition of calcium salts in the renal parenchyma. It is classified by ultrasonography into three types: cortical, medullary, and diffuse nephrocalcinosis . Cases of nephrocalcinosis in children are increasing and are becoming common causes for hospital admissions or visits to renal clinics. In addition, it is associated with significant long-term sequelae, including morbidity caused by recurrent stones as well as the development of chronic kidney disease (CKD). The exact pathogenesis of nephrocalcinosis remains under investigation, in medullary nephrocalcinosis the main cause is hypercalciuria. Increased urinary calcium load arises either through increased calcium absorption (extra-renal causes) or impaired calcium reabsorption within the renal tubule . The majority of calcium reabsorption (~65%) occurs in the proximal tubule, and (~25%) is reabsorbed in the thick ascending limb of the loop of Henle and (~5%) is reabsorbed from the cortical collecting duct . Identification of monogenic causes of nephrocalcinosis affecting these areas has provided valuable insights into the pathogenesis of this heterogeneous condition. Interestingly, although a further (~7-10% (of calcium is reabsorbed within the distal convoluted tubule, no monogenic causes of nephrocalcinosis have been identified which affect this section of the renal Tubule . Nephrocalcinosis can occur due to various metabolic or renal tubular disorders, Vitamin D excess, medication, and prematurity . The condition can progress to chronic kidney disease (CKD), and the renal prognosis is determined by its underlying cause, so a diagnostic evaluation in all children with NC to determine its causes and preserve kidney function is mandatory . Since the use of kidney ultrasound (US) as a routine diagnostic procedure, NC is detected in growing numbers of children. There is Different incidence rates and etiologies are reported in children with NC, reflecting the difference in geographic, genetic, and socioeconomic back ground. Classifications of NC, based on its US appearance, have been proposed, distinguishing medullary, cortical and global NC . It has also been stated that whether NC is harmful or not depends on its magnitude, and on whether it is the result of an ongoing problem or of a transient insult . Diagnosis of nephrocalcinosis is important to stop progression of renal injury. A detailed history should be obtained, including birth history, diet, fluid intake, medications, vitamin supplementation, developmental history, and other known diseases or conditions. A detailed family history also is very important. Physical examination findings are typically nonspecific, but the presence of signs that are syndromic in nature may provide helpful information to narrow the differential diagnosis .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 12 Years
Eligibility Inclusion Criteria: - • All patients aged from one month to 12 years diagnosed with nephrocalcinosis at pediatric department and nephrology outpatient clinic. Exclusion Criteria: - • Children with nephrolithiasis without nephrocalcinosis.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

References & Publications (3)

Habbig S, Beck BB, Hoppe B. Nephrocalcinosis and urolithiasis in children. Kidney Int. 2011 Dec;80(12):1278-91. doi: 10.1038/ki.2011.336. Epub 2011 Sep 28. Erratum In: Kidney Int. 2012 Aug;82(4):493-7. — View Citation

Hoppe B, Martin-Higueras C, Younsi N, Stein R. [Nephrolithiasis and nephrocalcinosis in children and adolescents]. Urologie. 2022 Oct;61(10):1099-1109. doi: 10.1007/s00120-022-01888-3. Epub 2022 Jul 8. German. — View Citation

Monet-Didailler C, Chateil JF, Allard L, Godron-Dubrasquet A, Harambat J. [Nephrocalcinosis in children]. Nephrol Ther. 2021 Feb;17(1):58-66. doi: 10.1016/j.nephro.2020.12.001. Epub 2021 Jan 15. French. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of nephrocalcinosis among renal diseases percentage of children presented with nephrocalcinosis among all children with renal diseses in sohag university hospital one year
Secondary Percentage of each risk factor of Nephrocalcinosis percentage of each risk factor related to Nephrocalcinosis in children in ssohag univesity hospital one year
See also
  Status Clinical Trial Phase
Withdrawn NCT00875823 - International Registry for Primary Hyperoxaluria N/A
Completed NCT04382976 - The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
Completed NCT00249951 - Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants Phase 3
Recruiting NCT00169806 - Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis N/A
Not yet recruiting NCT01756547 - Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature Phase 3
Active, not recruiting NCT04495608 - Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels Phase 2
Completed NCT02438267 - Preterm Infants and Nephrocalcinosis N/A