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

NCT03991845 | Unknown Phase 4 DMC

• 1 other identifier: INT/IEC/2017/1314
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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).

Conditions

Urticaria; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

Drug: Vit D

Placebo

NO INTERVENTION

No Vit D supplementation will be given to patients in this group

Interventions

Vit D DRUG

Vit D supplementation was done

Also known as: Levocetirizine 10 mg once daily will be given to all patients

High dose Vit D; Low dose Vit D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Urticaria; Vitamin D Deficiency

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Davinder Parsad, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: June 19, 2019
• Study Start: June 21, 2019
• Primary Completion: November 27, 2019
• Study Completion: December 28, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)