Study of the Effect of Combined Use of Vitamin D in Low-dose-oral immunotherapy for Children with Cow's Milk Allergy

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: D019587 The intervention will include the addition of vitamin D supplements to standard therapy. Intervene in a double‐blind design with placebo control. vitamin D CONDITION: Cow's milk allergy D016269 PRIMARY OUTCOME: Percentage of subjects with a positive oral food challenge test (OFC) after 6 months SECONDARY OUTCOME: Secondary efficacy endpoints; 1) Specific IgE and IgG4 levels before, 3 months after, and 6 months after the start of the study; 2) Vitamin D levels before the start of the study, 3 months after the start of the study, and 6 months after the start of the study; ; Secondary safety endpoints; 1) Specific allergic symptoms and the number of times they occurred during continuous intake of small amounts of milk; 2) Allergy‐inducing symptoms and treatment details of the oral challenge test (2.5 mL of milk) to be conducted 6 months after the start of intake of the study drug ; 3) Exacerbation of allergic comorbidities (atopic dermatitis, bronchial asthma, allergic rhinitis, allergic conjunctivitis) and drugs used; 4) Evaluation of vitamin D excess after three months and si Xmonths of the start of the study; 5) Number and percentage of adverse events (fever, respiratory tract symptoms, gastroenteritis symptoms) and serious adverse events that occurred during the study period INCLUSION CRITERIA: 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.
Epistemonikos ID: fd8e3fc915d6f0cca32de35a62e165bc49e74cc8
First added on: Aug 26, 2024