High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

Shiraz University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Urticaria

Treatments: Drug: Vitamin D3 (Low dose); Drug: Vitamin D3 (High dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT02873364

93-01-01-8312

Details and patient eligibility

About

Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks

Exclusion criteria

• Physical urticaria aquired or hereditary angioedema Calcium level > 10.3 mg/dl Glomerular filtration rate <50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Vitamin D3 (Low dose)

Active Comparator group

Description:

Daily 600 unites of vitamin D + Cetirizine 10mg twice a day

Treatment:

Drug: Vitamin D3 (Low dose)

Vitamin D3 (High dose)

Experimental group

Description:

Daily 4000 unites vitamin D + Cetirizine 10mg twice a day

Treatment:

Drug: Vitamin D3 (High dose)