NephrocalcinosisNCT05862207
Prevalence and Risk Factors of Nephrocalcinosis in Children at Sohag University Hospital
An observational study of Nephrocalcinosis, run by Sohag University.
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.
Ghada Ashry Borham, lecturer contact
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 .
- Conditions
- Nephrocalcinosis
- Medical subject headings
- Nephrocalcinosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted17 May 2023
- Study startJun 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NephrocalcinosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Saad Mohamed, Sohag University
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 33461896Hoppe 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 35925106Habbig 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Nephrocalcinosis in Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05862207
- Acronym / sponsor ID
- Nephrocalcinosis in children
- Conditions
- Nephrocalcinosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study prevalence, risk factors, possible etiologies, clinical presentation and outcome of nephrocalcinosis in children at Sohag University Hospital.
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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- • All patients aged from one month to 12 years diagnosed with nephrocalcinosis at pediatric department and nephrology outpatient clinic.
Key exclusion criteria (1 listed)
- • Children with nephrolithiasis without nephrocalcinosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of nephrocalcinosis among renal diseases
Time frame: one year
percentage of children presented with nephrocalcinosis among all children with renal diseses in sohag university hospital
1 secondary outcome
Percentage of each risk factor of Nephrocalcinosis
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Results publication: PubMed 33461896Monet-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.
- Results publication: PubMed 35925106Hoppe 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.
- Results publication: PubMed 21956187Habbig 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.
Related trials for Nephrocalcinosis
Not yet recruitingObservational study
Diagnostic Work-up of Nephrocalcinosis in Children
Nephrocalcinosis
Enrolling by invitationObservational study
Epidemiology and Risk Factors of Nephrolithiasis and Nephrocalcinosis With Pediatric Onset
Nephrocalcinosis
RecruitingPhase 2
Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria
Idiopathic Infantile Hypercalcaemia - Severe Form, Genetic Disease
Not yet recruitingPhase 2/3
The GranStone Trial
Paraffinoma, Granuloma, Foreign-Body
Active, not recruitingPhase 3
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
Autosomal Dominant Hypocalcemia (ADH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada Ashry Borham, lecturer contact
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.