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

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).

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency; Urticaria
• Intervention / Treatment: Drug: Vit D

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: Interventional
• Enrollment (Actual): 262
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	upto 12 weeks

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Davinder Parsad, MD, Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2019
• Primary Completion (ANTICIPATED): November 27, 2019
• Study Completion (ANTICIPATED): December 28, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (ACTUAL): June 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Nutrition Disorders; Skin Diseases, Vascular; Avitaminosis; Deficiency Diseases; Malnutrition; Hypersensitivity; Vitamin D Deficiency; Urticaria; Chronic Urticaria; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Levocetirizine
• Other Study ID Numbers: INT/IEC/2017/1314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No