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Набор по приглашению NCT06673082

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

Без фазы С лечением Cow Milk Protein Allergy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oral zinc supplementation, Placebo.
Кому может быть актуально
Состояния в реестре: Cow Milk Protein Allergy. Базовые параметры: 1 мес. — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • COMISS(Cow Milk Related symptom Score) [Срок оценки: 2 weeks]
Вторичные конечные точки (1)
  • COMISS (Cow Milk Related Symptom Score)and SCORAD (Severity Scoring of Atopic Dermatitis index) [Срок оценки: 4 Weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Другое

Центры проведения

Египет · 1 центр
  • faculty of medicine-Cairo universty — Giza

Идентификаторы

NCT: NCT06673082 · zinc in cow milk allergy · Arwa

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗