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

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.

NCT Number	NCT06673082
Lead Sponsor	Kasr El Aini Hospital
Conditions	Cow Milk Protein Allergy
Enrollment	190 participants
Start Date	2024-12-01
Primary Completion	2025-04-15 (estimated)
Study Completion	2025-05-15 (estimated)
Updated on ClinicalTrials.gov	2025-03-06