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

NCT06263140 | Completed DMC

• 1 other identifier: Chula-ARC 001/21
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

vitamin D; Stevens-Johnson Syndrome; Drug Reaction with Eosinophilia and Systemic Symptom; Maculopapular Exanthem; Drug Allergy; Drug Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Serum vitamin D levels

  Serum vitamin D levels at baseline

  At baseline

Study Arms (4)

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

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

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

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

Studied drug groups matched patients in group 1

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

Studied drug groups matched patients in group 2

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases: Subjects who develop drug-induced non-immediate cutaneous reactions Controls: subjects who can tolerate similar drug groups without allergic reactions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Drug Hypersensitivity Syndrome; Drug Eruptions; Vitamin D Deficiency; Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jettanong klaewsongkram, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 16, 2024
• Study Start: May 30, 2021
• Primary Completion: January 15, 2022
• Study Completion: February 1, 2022
• Last Updated: February 16, 2024

Record last verified: 2022-02

Locations

TH (1)