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

NCT06673082 · tracked via the Priya Life Science Egypt tracker

Sponsor

Kasr El Aini Hospital

Phase

Not applicable

Started

2024-12-01

Last updated

2025-03-06

Condition(s) studied

Cow Milk Protein Allergy

Investigational drug(s) / intervention(s)

Oral zinc supplementationPlacebo

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

Placebo: Oral

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.

Eligibility

Sex

ALL

Min age

1 Month

Max age

12 Years

Healthy volunteers

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 outcome measure(s)

COMISS(Cow Milk Related symptom Score) — 2 weeks
Evaluate the degree of change in COMISS Sc0re(Cow Milk Related symptom Score) between the interventional group and control group The COMISS Score ranges from 0 to 33. Each symptom has a maximal score of six,exception of respiratory symptoms(maximal score of three). a cut-off value\>12 was selected as the criterion to pick up infant at risk of Cow Milk Allergy . A score of 12 requires the presence of at least two severe symptoms and a score higher than10 requires the precense of at least three symptoms and the involvement of two organ systems

Trial sites (1)

Facility	City	Region	Status
faculty of medicine-Cairo universty	Giza	Egypt

More Kasr El Aini Hospital trials in Egypt

Gradual Versus Intermittent Release of Tourniquet Effect on MAP in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries Recruiting

Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault Enrolling by invitation

Exploring the Efficacy of Single-stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy, More Leak? Recruiting

Topical 2-Deoxy-D-ribose Hydrogel Versus Minoxidil 5% Solution for Androgenetic Alopecia Recruiting

Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma Recruiting

Other trials for the same condition

Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06673082 on ClinicalTrials.gov ↗ ← All trials in Egypt