NCT06673082

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Children who will be presented with manifestations of Cow Milk Protein Allergy will be enrolled in the study for Cow Milk -related Symptoms Score (CoMiSS) assessment. Detailed History, nutritional and clinical examination will be done to fulfill items of CoMiSS including skin manifestations as eczema , respiratory manifestations, GIT manifestations as constipation or diarrhea including Bristol scale and regurgitations and duration of crying . Children will be randomly allocated to two groups. Randomization will be done using GraphPad QuickCalcs software to allocate into either the interventional or control group. Oral Zinc will be supplemented to the interventional group on adose of 30 mg elemental zinc/day. 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 againto 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

Type	Name	Description
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

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-04-15
• Completion: 2025-05-15
• First posted: 2024-11-04
• Last updated: 2025-03-06

Locations

1 site across 1 country: Egypt