ClinicalTrials.gg
Sign In
CompletedNCT06263140Updated Feb 16, 2024

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

An observational study in Stevens-Johnson Syndrome, Drug Reaction With Eosinophilia and Systemic Symptom and Maculopapular Exanthem, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Chulalongkorn University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
15 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • 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
03

In context

Stevens-Johnson Syndrome

40 studies on the registry are indexed under Stevens-Johnson Syndrome; 8 are open to participants now.

Browse Stevens-Johnson Syndrome studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Browse Chulalongkorn University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Reactions from drugs with known strong genetic predispositions (allopurinol, carbamazepine, abacavir)
  • Receiving vitamin D supplement
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Serum vitamin D levels

    Serum vitamin D levels at baseline

    Time frame: At baseline

07

Study locations

1 site
  • Faculty of Medicine, Chulalongkorn University
    Bangkok, 10330, Thailand
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Jan 2022, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2022
First posted
Feb 16, 2024
StartActual
May 30, 2021
Primary completionActual
Jan 15, 2022
CompletionActual
Feb 1, 2022
Last update
Feb 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06263140
Lead sponsor
Chulalongkorn University
Responsible party
Sponsor
First posted
Feb 16, 2024
Start date
May 30, 2021
Primary completion
Jan 15, 2022
Completion
Feb 1, 2022
Last update
Feb 16, 2024

Study contacts

Jettanong klaewsongkram, MD
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stevens-Johnson Syndrome →

Other studies from this sponsor

Chulalongkorn University →

Start the discussion