Stevens-Johnson SyndromeNCT06263140
Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study
An observational study of Stevens-Johnson Syndrome and Drug Reaction With Eosinophilia and Systemic Symptom, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Serum vitamin D levels in drug-induced non-immediate reactions Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Stevens-Johnson Syndrome, Drug Reaction With Eosinophilia and Systemic Symptom, Maculopapular Exanthem
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 30 May 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases: Subjects who develop drug-induced non-immediate cutaneous reactions Controls: subjects who can tolerate similar drug groups without allergic reactions
Who may be able to join
- Diagnosed with SJS/TEN, DRESS, AGEP, MPE, or FDE as mentioned above
Who cannot join
- Reactions from drugs with known strong genetic predispositions (allopurinol, carbamazepine, abacavir)
- Receiving vitamin D supplement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- 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
- Medical subject headings
- Stevens-Johnson Syndrome, Drug Hypersensitivity Syndrome, Drug Eruptions, Vitamin D Deficiency, Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum vitamin D levels
Serum vitamin D levels at baseline
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start30 May 2021
- Primary completion15 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stevens-Johnson SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jettanong klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263140
- Sponsor's protocol ID
- Chula-ARC 001/21
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Vitamin D Levels in Patients With Non-immediate Drug Hypersensitivity, Case-control Study
- ClinicalTrials.gov ID
- NCT06263140
- Acronym / sponsor ID
- Chula-ARC 001/21
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Serum vitamin D levels in drug-induced non-immediate reactions
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases: Subjects who develop drug-induced non-immediate cutaneous reactions Controls: subjects who can tolerate similar drug groups without allergic reactions
Key inclusion criteria (1 listed)
- Diagnosed with SJS/TEN, DRESS, AGEP, MPE, or FDE as mentioned above
Key exclusion criteria (2 listed)
- Reactions from drugs with known strong genetic predispositions (allopurinol, carbamazepine, abacavir)
- Receiving vitamin D supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum vitamin D levels
Time frame: At baseline
Serum vitamin D levels at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jettanong klaewsongkram, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stevens-Johnson Syndrome and Drug Reaction With Eosinophilia and Systemic Symptom, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum vitamin D levels (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.