UrticariaPhase 3NCT02873364
High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria
A Phase 3 study testing Vitamin D3 (High dose) and Vitamin D3 (Low dose) in people with Urticaria, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Urticaria
- What is being tested?
- Vitamin D3 (High dose) and Vitamin D3 (Low dose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Aug 2016to Jan 2017
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks
Who cannot join
- Physical urticaria aquired or hereditary angioedema Calcium level > 10.3 mg/dl Glomerular filtration rate <50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shiraz University of Medical Sciences
Shiraz, Fars
Keramatallah Jahanshahi, MD, +989177416523, kjahanshahi91@gmail.com
About this study
Official title: High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria
Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.
- Conditions
- Urticaria
- Being tested
- Vitamin D3 (High dose), Vitamin D3 (Low dose)
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (High dose)Drug
Also called cholecalciferol
Daily 4000 unites vitamin D
Vitamin D3 (Low dose)Drug
Also called cholecalciferol
Daily 600 unites vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (Low dose) | Active comparator | Daily 600 unites of vitamin D + Cetirizine 10mg twice a day Receives: Drug: Vitamin D3 (Low dose) |
| Vitamin D3 (High dose) | Experimental | Daily 4000 unites vitamin D + Cetirizine 10mg twice a day Receives: Drug: Vitamin D3 (High dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urticaria symptom severity questionnaire after 1 week
Urticaria Symptom Severity ranging from 0 to 93
Measured: 1 weeks
Secondary outcomes (2)
Urticaria symptom severity questionnaire after 6 week
Urticaria Symptom Severity ranging from 0 to 93
Measured: 6 weeks
Urticaria symptom severity questionnaire after 12 week
Urticaria Symptom Severity ranging from 0 to 93
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keramatallah Jahanshahi, Shiraz University of Medical Sciences
- Investigators
- Keramatallah Jahanshahi, MD, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873364
- Sponsor's protocol ID
- 93-01-01-8312
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT02873364
- Acronym / sponsor ID
- 93-01-01-8312
- Conditions
- Urticaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- 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.
Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (Low dose) | Active comparator | Drug: Vitamin D3 (Low dose)Daily 600 unites of vitamin D + Cetirizine 10mg twice a day |
| Vitamin D3 (High dose) | Experimental | Drug: Vitamin D3 (High dose)Daily 4000 unites vitamin D + Cetirizine 10mg twice a day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks
Key exclusion criteria (1 listed)
- Physical urticaria aquired or hereditary angioedema Calcium level > 10.3 mg/dl Glomerular filtration rate <50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (High dose)Also: cholecalciferolDaily 4000 unites vitamin D | Drug | Vitamin D3 (High dose) |
| Vitamin D3 (Low dose)Also: cholecalciferolDaily 600 unites vitamin D | Drug | Vitamin D3 (Low dose) |
Primary outcome
Urticaria symptom severity questionnaire after 1 week
Time frame: 1 weeks
Urticaria Symptom Severity ranging from 0 to 93
2 secondary outcomes
Urticaria symptom severity questionnaire after 6 week
Time frame: 6 weeks
Urticaria symptom severity questionnaire after 12 week
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
Keramatallah Jahanshahi, MD principal investigator
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 (High dose) and Vitamin D3 (Low dose) in people with Urticaria, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2016. 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keramatallah Jahanshahi, MD (+989177416523, kjahanshahi91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urticaria symptom severity questionnaire after 1 week (time frame: 1 weeks). 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 19 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.