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

NCT ID: NCT06263140

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-30

Study Completion Date

2022-02-01

Brief Summary

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

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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

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

No interventions assigned to this group

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

Studied drug groups matched patients in group 1

No interventions assigned to this group

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

Studied drug groups matched patients in group 2

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jettanong klaewsongkram, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Chula-ARC 001/21

Identifier Type: -

Identifier Source: org_study_id

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