Clinical trial NCT06673082: Impact of Zinc as a New Adjuvant Therapy for Cow Milk Protein Allergy in Children.
Official title: Impact of Zinc as a New Adjuvant Therapy for Cow Milk Protein Allergy in Children, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cow Milk Protein Allergy
Keywords: Zinc
Cow Milk Protein Allergy
COMISS
SCORAD
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 190
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group will receive oral Zinc therapy while the other group will recieve placebo
Primary purpose: OTHER

Brief summary: Children presented with manifestations of Cow Milk Protein Allergy will be enrolled for Cow Milk -related Symptoms Score (CoMiSS assessment). Detailed History, nutritional and clinical examination will be done to fulfill items of CoMiSS. Children will be randomly allocated to two groups. Oral Zinc will be supplemented to the interventional group. CoMiSS will be recorded at the baseline and weekly till 4 weeks. Then Oral Food Challenge (OFC) will be done to confirm the diagnosis and CoMiSS assessment will be recorded again to see if Zinc has any modulatory effect on reappearance of symptoms. The people administering the intervention, the people assessing the outcomes, the patients and their caregivers will all be blinded to the type of treatment.

Children who will be presented with skin manifestation will be assessed by Severity Scoring of Atopic Dermatitis Index (SCORAD score) once diagnosed and weekly till 4 weeks after zinc supplementation to see if Zinc has any modulatory effect.

Detailed description: Children who will be presented with manifestations of Cow Milk Protein Allergy will be enrolled in the study for Cow Milk -related Symptoms Score (CoMiSS) assessment.

Detailed History, nutritional and clinical examination will be done to fulfill items of CoMiSS including skin manifestations as eczema , respiratory manifestations, GIT manifestations as constipation or diarrhea including Bristol scale and regurgitations and duration of crying .

Children will be randomly allocated to two groups. Randomization will be done using GraphPad QuickCalcs software to allocate into either the interventional or control group. Oral Zinc will be supplemented to the interventional group on adose of 30 mg elemental zinc/day.

CoMiSS will be recorded at the baseline and weekly till 4 weeks. Then Oral Food Challenge (OFC) will be done to confirm the diagnosis and CoMiSS assessment will be recorded againto see if Zinc has any modulatory effect on reappearance of symptoms. The people administering the intervention, the people assessing the outcomes, the patients and their caregivers will all be blinded to the type of treatment.

Children who will be presented with skin manifestation will be assessed by Severity Scoring of Atopic Dermatitis Index (SCORAD score) once diagnosed and weekly till 4 weeks after zinc supplementation to see if Zinc has any modulatory effect.

Eligibility criteria: Inclusion Criteria:

Children suspected to have Cow Milk Protein Allergy using Cow's Milk-relatedSymptoms Score with a Score more than12 Age less than 12 years old both sexes Whose parents approved to be enrolled in the study

Exclusion Criteria:

Children with Comorbidities that may affect the duration of treatment as dysphagia.

History of Severe allergic reaction that required hospital admission as Ora Food Challenge is expectedto be delayed in these patients.

-Multiple Food Allergies

Primary outcomes:
measure: COMISS(Cow Milk Related symptom Score)
timeFrame: 2 weeks
Secondary outcomes:
measure: COMISS (Cow Milk Related Symptom Score)and SCORAD (Severity Scoring of Atopic Dermatitis index)
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of medicine-Cairo universty
Study officials:
affiliation: Cairo University
name: Nabil Abdelaziz, Professor of Pediatrics
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Dalia Sayed Mosallam, Professor of Pediatrics
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Hoda Atef Abdel Sattar, Lecturer of Pediatrics
role: PRINCIPAL_INVESTIGATOR
References: