Study of the Effect of Combined Use of Vitamin D in Low-dose-oral immunotherapy for Children with Cow's Milk AllergyDouble-Blind, Randomized, Placebo-Controlled Trial

akano Taiji0 个研究点目标入组 24 人开始时间: 2023年1月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Children 3 to 8 years of age with cow's milk allergy at the time of consent
•2) A confirmed diagnosis of IgE-dependent cow's milk allergy (symptoms eliciting an allergic immediate reaction to cow's milk ingestion)
•3) Blood vitamin D concentration less than 30 ng/mL before the start of the study
•4) Children who can make regular visits to Chiba University Hospital or who live near an emergency hospital
•5) Patients who have received a thorough explanation of their participation in this study and who have obtained the free and voluntary written consent of the patient and the patient's surrogate after fully understanding the study.

•1) Children with gastrointestinal allergy-related diseases (neonatal/infantile food protein-induced gastroenteropathy)
•2) Children who have difficulty discontinuing oral medications before the oral challenge test due to underlying disease management
•3) Children with a history of anaphylactic shock
•4) Blood vitamin D level of > 30 ng/mL before study entry
•5) Patients with hypercalcemia and hypermagnesemia
•6) Children who had anaphylactic symptoms as a result of the initial food oral load test (0.5 mL of milk) in the screening test
•7) Children who were asymptomatic in the second food oral challenge test (2.5 mL of milk) of the screening test
•8) Patients who are regularly taking steroids or immunosuppressive drugs (inhaled steroids and steroid ointments are allowed)
•9) Patients with poorly controlled bronchial asthma or atopic dermatitis
•10) Patients with serious underlying diseases (e.g., leukemia)
•11) Other patients who are judged by the principal investigator or sub-investigator to be unsuitable for the safe conduct of this study

发起方

akano Taiji