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

JRCT ID: jRCTs031220589

Registered date:26/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cow's milk allergy
• Date of first enrollment: 26/01/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

The intervention will include the addition of vitamin D supplements to standard therapy.
Intervene in a double-blind design with placebo control.

Outcome(s)

• Primary Outcome: Percentage of subjects with a positive oral food challenge (OFC) test with 4-5 times the volume of milk maintenance intake six months after the start of the study.

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 (4-5 times the volume of milk maintenance intake) 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 six months 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

Key inclusion & exclusion criteria

• Age minimum: >= 3age old
• Age maximum: <= 8age old
• Gender: Both

Include 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.

Exclude criteria

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 with anaphylactic symptoms after ingesting 0.1 mL of milk
7) Children who can take 12.5 mL of milk
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

Related Information

• Primary Sponsor: Nakano Taiji
• Secondary Sponsor: Clinical Research Initiation Fund of Chiba University Hospital