Cow Milk Protein AllergyNCT06673082
Impact of Zinc as a New Adjuvant Therapy for Cow Milk Protein Allergy in Children.
A study testing Oral zinc supplementation in people with Cow Milk Protein Allergy, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Cow Milk Protein Allergy
- What is being tested?
- Oral zinc supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Zinc as a New Adjuvant Therapy for Cow Milk Protein Allergy in Children, A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Oral zinc supplementation, Placebo
- Keywords
- Zinc, Cow Milk Protein Allergy, COMISS, SCORAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral zinc supplementationDrug
Oral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day.
PlaceboOther
Oral
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | Oral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day. Receives: Drug: Oral zinc supplementation |
| control group | Placebo comparator | oral placebo identical to Zinc inappearance and packaging Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (1)
COMISS (Cow Milk Related Symptom Score)and SCORAD (Severity Scoring of Atopic Dermatitis index)
- Degree of change clinicaiiy by SCORAD (Severity Scoring of Atopic Dermatitis index) between the intervention and control group upon Zinc adminstration. SCORAD is a clinical tool used to assess the extent and severity of eczema, To determine extent by is the 'rule of nine': 9% for the head and neck, each arm, the front and back of each leg, the four trunk quadrants, and 1% for the genitalia, The intensity part of the index consists of six items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness. Each item can be graded on a scale 0-3 pruritus and sleeplessness (0-10)for each, SCORAD score range is between 0 and 103 points and defines three classes of AD severity (. mild if SCORAD <25, moderate if 25 ≤ SCORAD ≤ 50 and severe if SCORAD > 50.
- The Change in the degree of improvement between the interventional and control group based on COMISS score at 1,2, 3, and 4 weeks.
2.Time to improvement of COMISS score below 12 in both groups.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Dec 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk Protein AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group will receive oral Zinc therapy while the other group will recieve placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Ahmed, Kasr El Aini Hospital
- Investigators
- Nabil Abdelaziz, Professor of Pediatrics, Principal investigator, Cairo UniversityDalia Sayed Mosallam, Professor of Pediatrics, Principal investigator, Cairo UniversityHoda Atef Abdel Sattar, Lecturer of Pediatrics, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673082
- Sponsor's protocol ID
- zinc in cow milk allergy
- Other IDs
- Arwa
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Zinc as a New Adjuvant Therapy for Cow Milk Protein Allergy in Children, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06673082
- Acronym / sponsor ID
- zinc in cow milk allergy
- Conditions
- Cow Milk Protein Allergy
- Keywords
- Zinc, Cow Milk Protein Allergy, COMISS, SCORAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one group will receive oral Zinc therapy while the other group will recieve placebo
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Drug: Oral zinc supplementationOral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day. |
| control group | Placebo comparator | Other: Placebooral placebo identical to Zinc inappearance and packaging |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral zinc supplementationOral Zinc will be supplemented to the interventional group on a dose of 30 mg elemental zinc/day. | Drug | interventional group |
| PlaceboOral | Other | control group |
Primary outcome
COMISS(Cow Milk Related symptom Score)
Time frame: 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
1 secondary outcome
COMISS (Cow Milk Related Symptom Score)and SCORAD (Severity Scoring of Atopic Dermatitis index)
Time frame: 4 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabil Abdelaziz, Professor of Pediatrics principal investigator
Cairo University
Dalia Sayed Mosallam, Professor of Pediatrics principal investigator
Cairo University
Hoda Atef Abdel Sattar, Lecturer of Pediatrics principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral zinc supplementation in people with Cow Milk Protein Allergy, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMISS(Cow Milk Related symptom Score) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.