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

NCT06673082 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Cow Milk Protein Allergy

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

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Nabil Abdelaziz, Professor of Pediatrics · Cairo University

  • Dalia Sayed Mosallam, Professor of Pediatrics · Cairo University

  • Hoda Atef Abdel Sattar, Lecturer of Pediatrics · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-04-15
Completion
2025-05-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06673082 on ClinicalTrials.gov