ClinicalTrials.gg
CompletedNCT06494852Updated Jul 10, 2024

Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy

An observational study in Cow's Milk Protein Allergy and Rta, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 3 Months to 3 Years. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
120
Ages
3 Months to 3 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cow's Milk Protein Allergy
  • Rta

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Keywords

  • CMPA / RTA
03

In context

Milk Hypersensitivity

147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.

This study's enrollment of 120 is above the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.

Browse Milk Hypersensitivity studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testinvestigations

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

07

Study locations

1 site
  • Sohag
    Sohag, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided — not decided yet if i will share my IPD or not

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Dec 2023, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2024
First posted
Jul 10, 2024
StartActual
Jun 3, 2023
Primary completionActual
Dec 3, 2023
CompletionActual
Jan 3, 2024
Last update
Jul 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06494852
Lead sponsor
Sohag University
Responsible party
Esraa Mohamed Hedia (MBBCh, Sohag University) — Principal investigator
First posted
Jul 10, 2024
Start date
Jun 3, 2023
Primary completion
Dec 3, 2023
Completion
Jan 3, 2024
Last update
Jul 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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