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

February 14, 2024 updated by: Chulalongkorn University

A Study of Vitamin D Levels in Patients With Non-immediate Drug Hypersensitivity, Case-control Study

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

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum vitamin D levels
Time Frame: At baseline
Serum vitamin D levels at baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chula-ARC 001/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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