Trials Sponsors Conditions Drugs Pricing

Conditions

Cow Milk Protein Allergy

Keywords

ZincCow Milk Protein AllergyCOMISSSCORAD

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 supplementationDrug

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

interventional group

PlaceboOther

Oral

control group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Month - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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:

Sponsors & Collaborators

Kasr El Aini Hospital
Otherlead

Study Sites (1)

faculty of medicine-Cairo universty

Giza, 12556, Egypt

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

Study Record Dates

First Submitted

October 22, 2024

First Posted

November 4, 2024

Study Start

December 1, 2024

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

interventional group

control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

interventional group

control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Data Sharing

Source record

Locations