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ENROLLING BY INVITATION
NCT06673082
NA

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

Sponsor: Kasr El Aini Hospital

View on ClinicalTrials.gov

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.

Official title: Impact of Zinc as a New Adjuvant Therapy for Cow Milk Protein Allergy in Children, A Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Month - 12 Years

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2024-12-01

Completion Date

2025-05-15

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

DRUG

Oral zinc supplementation

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

OTHER

Placebo

Oral

Locations (1)

faculty of medicine-Cairo universty

Giza, Egypt