Cow's Milk Protein AllergyNCT06494852
Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy
An observational study of Cow's Milk Protein Allergy and Rta, run by Sohag University at 1 site in Egypt.
Trial summary
Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Cow's Milk Protein Allergy, Rta
- What is being tested?
- investigations
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2023to 3 Jan 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 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years
Who may be able to join
- Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction.
Read the detailed description
This is a cross-sectional study that will be conducted over 6 months at the pediatric department, Sohag University Hospital, Sohag, Egypt.
Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study.
The study participants will be subjected to full history taking and thorough clinical examination at the pediatric outpatient clinic and their medical files will be reviewed.
- Conditions
- Cow's Milk Protein Allergy, Rta
- Being tested
- investigations
- Keywords
- CMPA / RTA
- Medical subject headings
- Milk Hypersensitivity, Acidosis, Renal Tubular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigationsDiagnostic test
laboratory assesment Kidney function test, Urine analysis, Arterial blood gases ,Electrolytes (Na,K,Cl,Ca,phosphorus) and Calcium/creatinine ratio , Total serum IgE Radiological assessment Abdominal ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate association of Renal tubular acidosis in cow milk protein allergy patients
Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start3 Jun 2023
- Primary completion3 Dec 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein AllergyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Hedia, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494852
- Sponsor's protocol ID
- Soh-Med-24-5-02MS
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet if i will share my IPD or not
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT06494852
- Acronym / sponsor ID
- Soh-Med-24-5-02MS
- Conditions
- Cow's Milk Protein Allergy, Rta
- Keywords
- CMPA / RTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 10 Jul 2024 (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.
Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction.
Detailed description
This is a cross-sectional study that will be conducted over 6 months at the pediatric department, Sohag University Hospital, Sohag, Egypt.
Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study.
The study participants will be subjected to full history taking and thorough clinical examination at the pediatric outpatient clinic and their medical files will be reviewed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years
Key inclusion criteria (1 listed)
- Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| investigationslaboratory assesment Kidney function test, Urine analysis, Arterial blood gases ,Electrolytes (Na,K,Cl,Ca,phosphorus) and Calcium/creatinine ratio , Total serum IgE Radiological assessment Abdominal ultrasonography | Diagnostic test | – |
Primary outcome
investigate association of Renal tubular acidosis in cow milk protein allergy patients
Time frame: 6 months
Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: Undecided. not decided yet if i will share my IPD or not
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Protein Allergy and Rta, run by Sohag University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate association of Renal tubular acidosis in cow milk protein allergy patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2024.