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出境医 / 临床实验 / A Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria

A Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria

Study Description
Brief 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. 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).

Condition or disease Intervention/treatment Phase
Urticaria Vitamin D Deficiency Drug: Vit D Phase 4

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : November 27, 2019
Estimated Study Completion Date : December 28, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Low dose Vit D
All Patients belonging to arm 1 will be treated with low dose oral Vit D (2000 IU/day) for 12 weeks
 Drug: Vit D
Vit D supplementation was done
Other Name: Levocetirizine 10 mg once daily will be given to all patients
Active Comparator: High dose Vit D
All patients in this group will be treated with high dose oral Vit D (60,000 IU/week) for 12 weeks
 Drug: Vit D
Vit D supplementation was done
Other Name: Levocetirizine 10 mg once daily will be given to all patients
No Intervention: Placebo
No Vit D supplementation will be given to patients in this group
Outcome Measures
Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults >18 years of age, having urticaria episodes at least 2 days per week for 6 weeks or longer with/without angioedema.

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
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India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Layout table for investigator information
Principal Investigator: Davinder Parsad, MD Postgraduate Institute of Medical Education and Research
Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE June 21, 2019
Estimated Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria
Official Title  ICMJE A Randomised Controlled Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Urticaria
  • Vitamin D Deficiency
Intervention  ICMJE Drug: Vit D
Vit D supplementation was done
Other Name: Levocetirizine 10 mg once daily will be given to all patients
Study Arms  ICMJE
  • Experimental: Low dose Vit D
    All Patients belonging to arm 1 will be treated with low dose oral Vit D (2000 IU/day) for 12 weeks
    Intervention: Drug: Vit D
  • Active Comparator: High dose Vit D
    All patients in this group will be treated with high dose oral Vit D (60,000 IU/week) for 12 weeks
    Intervention: Drug: Vit D
  • No Intervention: Placebo
    No Vit D supplementation will be given to patients in this group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 17, 2019) 		262
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 28, 2019
Estimated Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults >18 years of age, having urticaria episodes at least 2 days per week for 6 weeks or longer with/without angioedema.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991845
Other Study ID Numbers  ICMJE INT/IEC/2017/1314
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Davinder Parsad, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Davinder Parsad, MD Postgraduate Institute of Medical Education and Research
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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