Impact of Zinc as a New Adjuvant Therapy for Cow Milk Protein Allergy in Children.

NCT ID: NCT06673082

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-05-15

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.

Conditions

Cow Milk Protein Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

interventional group

Oral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day.

Group Type: EXPERIMENTAL

Oral zinc supplementation

Intervention Type: DRUG

Oral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day.

control group

oral placebo identical to Zinc inappearance and packaging

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral

Interventions

Oral zinc supplementation

Oral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day.

Intervention Type: DRUG

Placebo

Oral

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Arwa Ahmed

pediatric specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nabil Abdelaziz, Professor of Pediatrics

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Dalia Sayed Mosallam, Professor of Pediatrics

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Hoda Atef Abdel Sattar, Lecturer of Pediatrics

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

faculty of medicine-Cairo universty

Giza, , Egypt

Countries

Egypt

Other Identifiers

Arwa

Identifier Type: OTHER

Identifier Source: secondary_id

zinc in cow milk allergy

Identifier Type: -

Identifier Source: org_study_id