Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study

Chulalongkorn University

Status: Completed

Conditions: Drug Reaction With Eosinophilia and Systemic Symptom; Drug-Induced Rash; Vitamin D Deficiency; Maculopapular Exanthem; Stevens-Johnson Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT06263140

Chula-ARC 001/21

Details and patient eligibility

About

Serum vitamin D levels in drug-induced non-immediate reactions

Full description

The study of serum vitamin D levels in patients presented with drug-induced non-immediate cutaneous adverse reactions compared to those in drug-tolerant control subjects

Enrollment: 120 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with SJS/TEN, DRESS, AGEP, MPE, or FDE as mentioned above

Exclusion criteria

• Reactions from drugs with known strong genetic predispositions (allopurinol, carbamazepine, abacavir)
• Receiving vitamin D supplement

Trial design

120 participants in 4 patient groups

1. Patients diagnosed with drug-induced severe non-immediate cutaneous reactions

Description:

Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptom (DRESS), acute generalized exanthematous pustulosis (AGEP)

2. Patients diagnosed with drug-induced non-severe non-immediate cutaneous reactions

Description:

Maculopapular exanthem (MPE), fixed drug eruption (FDE)

3. Subjects who tolerated drugs potentially causing severe non-immediate cutaneous reactions

Description:

Studied drug groups matched patients in group 1

4. Subjects who tolerated drugs potentially causing non-severe non-immediate cutaneous reactions

Description:

Studied drug groups matched patients in group 2