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NephrocalcinosisNCT05862207

Prevalence and Risk Factors of Nephrocalcinosis in Children at Sohag University Hospital

An observational study of Nephrocalcinosis, run by Sohag University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 1 month to 12 years
Conditions the study is for
Nephrocalcinosis
How many people
50 participants
Where
No sites listed yet
Study dates
Jun 2023to May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: all infants and children diagnosed with nephrocalcinosis and followed up at our pediatric nephrology clinic and pediatric department at Sohag University Hospitals during the study duration

Who may be able to join

  • • All patients aged from one month to 12 years diagnosed with nephrocalcinosis at pediatric department and nephrology outpatient clinic.

Who cannot join

  • • Children with nephrolithiasis without nephrocalcinosis.

Trial locations and contacts

No sites are listed yet.

Menna Saad Mohamed, master degree contact

0158112682

menasaad@med.sohag.edu.eg

Ghada Ashry Borham, lecturer contact

01068479255

About this study

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

Read the detailed 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 .

Medical subject headings
Nephrocalcinosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage of nephrocalcinosis among renal diseases

    percentage of children presented with nephrocalcinosis among all children with renal diseses in sohag university hospital

    Measured: one year

Secondary outcomes (1)
  1. Percentage of each risk factor of Nephrocalcinosis

    percentage of each risk factor related to Nephrocalcinosis in children in ssohag univesity hospital

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study startJun 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05862207
Sponsor's protocol ID
Nephrocalcinosis in children
Status last verified
Jun 2023
First submitted
8 May 2023
Last updated
13 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33461896
  • 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.

    PubMed 35925106
  • 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.

    PubMed 21956187

Questions about this trial

What is this clinical trial studying?

An observational study of Nephrocalcinosis, run by Sohag University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Menna Saad Mohamed, master degree (0158112682, menasaad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of nephrocalcinosis among renal diseases (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05862207, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.

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