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

• Status: Unknown status
• Trial end date: 2019-12-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Levocetirizine; Vitamin D

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.