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

NCT06673082 | Enrolling By Invitation DMC

• 2 other identifiers: zinc in cow milk allergyArwa
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow Milk Protein Allergy

Keywords

Zinc; Cow Milk Protein Allergy; COMISS; SCORAD

Outcome Measures

Primary Outcomes (1)

• COMISS(Cow Milk Related symptom Score)

  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

  2 weeks

Secondary Outcomes (1)

• COMISS (Cow Milk Related Symptom Score)and SCORAD (Severity Scoring of Atopic Dermatitis index)

  4 Weeks

Study Arms (2)

interventional group

EXPERIMENTAL

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

Drug: Oral zinc supplementation

control group

PLACEBO COMPARATOR

oral placebo identical to Zinc inappearance and packaging

Other: Placebo

Interventions

Oral zinc supplementation DRUG

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

interventional group

Placebo OTHER

Oral

control group

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

faculty of medicine-Cairo universty

Giza, 12556, Egypt

Location

Study Officials

• Nabil Abdelaziz, Professor of Pediatrics

  Cairo University

  PRINCIPAL INVESTIGATOR

• Dalia Sayed Mosallam, Professor of Pediatrics

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hoda Atef Abdel Sattar, Lecturer of Pediatrics

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric specialist

Model Details: one group will receive oral Zinc therapy while the other group will recieve placebo

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 4, 2024
• Study Start: December 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 15, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)