UrticariaPhase 4NCT03991845
A Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria
A Phase 4 study testing Vit D in people with Urticaria and Vitamin D Deficiency, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
This study will be an assessor-blind, randomized controlled trial in patients with CSU. The investigators will compared Vit D level in patients with Chronic spontaneous urticaria (CSU) and controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urticaria, Vitamin D Deficiency
- What is being tested?
- Vit D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jun 2019to 28 Dec 2019
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults >18 years of age, having urticaria episodes at least 2 days per week for 6 weeks or longer with/without angioedema.
Who cannot join
- Patients with only physical urticaria, only dermatographism, urticarial vasculitis, hereditary or acquired angioedema.
- Patients with BMI>25 kg/m2, dyslipidemia, diabetes, hypertension, pre-existing cardiovascular disease, cerebro-vascular accidents, hypothyroidism, smokers, and other systemic or cutaneous disorders including atopic dermatitis, psoriasis etc.
- Patients with hypercalcemia (>11 mg/dL), diabetes, renal insufficiency, hepatic disorders, hyperparathyroidism, sarcoidosis, other granulomatous disorders, malignancy.
- Pregnant and lactating women, patients who have taken Vit D supplementation in past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria
This study will be an assessor-blind, randomized controlled trial in patients with CSU. The investigators will compared Vit D level in patients with Chronic spontaneous urticaria (CSU) and controls. Enrolled CSU patients with Vit D level <30ng/ml will be then randomized into three intervention arms in the ratio of 1:1:1. Patients belonging to intervention group A will be treated with low dose Vit D (2000 IU/day) for 12 weeks according to the Indian council of medical research (ICMR) guidelines. Intervention group B patients will be treated with high dose Vit D (60,000 IU/week) for 12 weeks and group C will not be given any Vit D supplements. All patients will be evaluated after 12 weeks. The urticaria activity score over 4 days (UAS4) will be used to assess the disease severity using the number of wheals and pruritus intensity based on the EAACI/GA2LEN/EDF guidelines. The patient's disease severity levels will be graded as mild (0-8), moderate (9-16), and severe (17-24).
Read the detailed description
This is a prospective, randomized, single-centre clinical study. Serum Vit D level will be assessed in all patients at baseline. Patients with Vit D level ≥30 will be excluded from the trial but included in the study and those with Vit D level <30 will be randomized into 3 groups A, B and C. Patients with Vit D level ≥30 will be categorized into Group D. Patients belonging to Group A will be treated with low dose Vit D (2000 IU/day) according to Indian council of medical research (ICMR) guidelines. Those in Group B will be treated with high dose Vit D (60,000 IU/week) and group C will not be given any Vit D supplements. Patients belonging to Group A and B will be treated for 12 weeks in order to safely restore Vit D and achieve a steady state. In addition levocetirizine, 10 mg will be given to all patients in groups to control urticaria symptoms. All patients will be treated according to EAACI/GA2LEN/EDF guidelines after 12 weeks. All participants will also be provided with rescue prednisone use for intolerable or uncontrolled symptoms. At 6 weeks and 12 weeks, a physician assessment (physician blinded to treatment arm) will be conducted to check if patients had intolerable symptoms or took rescue prednisolone 40 mg therapy. Safety monitoring will be completed throughout the entirety of the study. Specific stopping rules and discontinuation of the study included pregnancy, a serum Vit D level higher than 100 ng/mL, or a serum calcium level higher than 11 mg/dL. Patients will be followed for 6 weeks after the study completion and thereafter data analysis will be done in 3 steps:
Step 1: Comparison of serum Vit D level in CSU patients vs. controls Step 2 : Assessment of factors associated with Vit D deficiency in urticaria patients Step 3: Effect of Vit D supplementation (group A (low dose), group B (high dose), group C(no supplementation) on urticaria severity using UAS4
- Conditions
- Urticaria, Vitamin D Deficiency
- Being tested
- Vit D
- Medical subject headings
- Urticaria, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit DDrug
Also called Levocetirizine 10 mg once daily will be given to all patients
Vit D supplementation was done
| Study group | Role | What they receive |
|---|---|---|
| Low dose Vit D | Experimental | All Patients belonging to arm 1 will be treated with low dose oral Vit D (2000 IU/day) for 12 weeks Receives: Drug: Vit D |
| High dose Vit D | Active comparator | All patients in this group will be treated with high dose oral Vit D (60,000 IU/week) for 12 weeks Receives: Drug: Vit D |
| Placebo | No intervention | No Vit D supplementation will be given to patients in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urticaria Activity Score- UAS 4
Urticaria activity score (UAS) over previous 4 days i.e 4 days before starting treatment and second reading after 12 weeks. It includes calculation of wheals and itching over past 4 days on a scale of 0-3 making a total score of 6 per day and total score of 24 of past 4 days. Maximum score 24, minimum score 0, range 0-24. No subscale will be assessed . 0 indicated no disease and 24 indicates maximum severity. The readings will be taken before and after treatment completion. Change in UAS before starting treatment, and at 12 weeks follow-up visit will be used to assess the efficacy of intervention. Intervention will be stopped at 12 weeks.
Measured: upto 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 Jun 2019
- Study start21 Jun 2019
- Primary completion27 Nov 2019 (estimated)
- Study completion28 Dec 2019 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davinder Parsad, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Davinder Parsad, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991845
- Sponsor's protocol ID
- INT/IEC/2017/1314
- Status last verified
- Jun 2019
- First submitted
- 29 Jan 2018
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria
- ClinicalTrials.gov ID
- NCT03991845
- Acronym / sponsor ID
- INT/IEC/2017/1314
- Conditions
- Urticaria, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 27 Nov 2019 (estimated)
- Study completion
- 28 Dec 2019 (estimated)
- First posted
- 19 Jun 2019 (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.
This study will be an assessor-blind, randomized controlled trial in patients with CSU. The investigators will compared Vit D level in patients with Chronic spontaneous urticaria (CSU) and controls. Enrolled CSU patients with Vit D level <30ng/ml will be then randomized into three intervention arms in the ratio of 1:1:1. Patients belonging to intervention group A will be treated with low dose Vit D (2000 IU/day) for 12 weeks according to the Indian council of medical research (ICMR) guidelines. Intervention group B patients will be treated with high dose Vit D (60,000 IU/week) for 12 weeks and group C will not be given any Vit D supplements. All patients will be evaluated after 12 weeks. The urticaria activity score over 4 days (UAS4) will be used to assess the disease severity using the number of wheals and pruritus intensity based on the EAACI/GA2LEN/EDF guidelines. The patient's disease severity levels will be graded as mild (0-8), moderate (9-16), and severe (17-24).
Detailed description
This is a prospective, randomized, single-centre clinical study. Serum Vit D level will be assessed in all patients at baseline. Patients with Vit D level ≥30 will be excluded from the trial but included in the study and those with Vit D level <30 will be randomized into 3 groups A, B and C. Patients with Vit D level ≥30 will be categorized into Group D. Patients belonging to Group A will be treated with low dose Vit D (2000 IU/day) according to Indian council of medical research (ICMR) guidelines. Those in Group B will be treated with high dose Vit D (60,000 IU/week) and group C will not be given any Vit D supplements. Patients belonging to Group A and B will be treated for 12 weeks in order to safely restore Vit D and achieve a steady state. In addition levocetirizine, 10 mg will be given to all patients in groups to control urticaria symptoms. All patients will be treated according to EAACI/GA2LEN/EDF guidelines after 12 weeks. All participants will also be provided with rescue prednisone use for intolerable or uncontrolled symptoms. At 6 weeks and 12 weeks, a physician assessment (physician blinded to treatment arm) will be conducted to check if patients had intolerable symptoms or took rescue prednisolone 40 mg therapy. Safety monitoring will be completed throughout the entirety of the study. Specific stopping rules and discontinuation of the study included pregnancy, a serum Vit D level higher than 100 ng/mL, or a serum calcium level higher than 11 mg/dL. Patients will be followed for 6 weeks after the study completion and thereafter data analysis will be done in 3 steps:
Step 1: Comparison of serum Vit D level in CSU patients vs. controls Step 2 : Assessment of factors associated with Vit D deficiency in urticaria patients Step 3: Effect of Vit D supplementation (group A (low dose), group B (high dose), group C(no supplementation) on urticaria severity using UAS4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose Vit D | Experimental | Drug: Vit DAll Patients belonging to arm 1 will be treated with low dose oral Vit D (2000 IU/day) for 12 weeks |
| High dose Vit D | Active comparator | Drug: Vit DAll patients in this group will be treated with high dose oral Vit D (60,000 IU/week) for 12 weeks |
| Placebo | No intervention | –No Vit D supplementation will be given to patients in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults >18 years of age, having urticaria episodes at least 2 days per week for 6 weeks or longer with/without angioedema.
Key exclusion criteria (4 listed)
- Patients with only physical urticaria, only dermatographism, urticarial vasculitis, hereditary or acquired angioedema.
- Patients with BMI>25 kg/m2, dyslipidemia, diabetes, hypertension, pre-existing cardiovascular disease, cerebro-vascular accidents, hypothyroidism, smokers, and other systemic or cutaneous disorders including atopic dermatitis, psoriasis etc.
- Patients with hypercalcemia (>11 mg/dL), diabetes, renal insufficiency, hepatic disorders, hyperparathyroidism, sarcoidosis, other granulomatous disorders, malignancy.
- Pregnant and lactating women, patients who have taken Vit D supplementation in past 6 months.
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 |
|---|---|---|
| Vit DAlso: Levocetirizine 10 mg once daily will be given to all patientsVit D supplementation was done | Drug | High dose Vit D, Low dose Vit D |
Primary outcome
Change in Urticaria Activity Score- UAS 4
Time frame: upto 12 weeks
Urticaria activity score (UAS) over previous 4 days i.e 4 days before starting treatment and second reading after 12 weeks. It includes calculation of wheals and itching over past 4 days on a scale of 0-3 making a total score of 6 per day and total score of 24 of past 4 days. Maximum score 24, minimum score 0, range 0-24. No subscale will be assessed . 0 indicated no disease and 24 indicates maximum severity. The readings will be taken before and after treatment completion. Change in UAS before starting treatment, and at 12 weeks follow-up visit will be used to assess the efficacy of intervention. Intervention will be stopped at 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Davinder Parsad, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vit D in people with Urticaria and Vitamin D Deficiency, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 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 24 Jun 2019. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Change in Urticaria Activity Score- UAS 4 (time frame: upto 12 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 24 Jun 2019.