Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation

Conditions

• Urticaria

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vitamin D (4,000 IU/day) — DIETARY_SUPPLEMENT
  High Dose of 4,000 IU/day.
• Vitamin D (400 IU/day) — DIETARY_SUPPLEMENT
  Low Dose of 400 IU/day.
• Omalizumab — DRUG
  Standard of care dose.

Study Details

The proposed research is intended to determine if supplementation of relatively high dose vitamin D in chronic urticaria patients receiving omalizumab will result in continued symptomatic control of hives after the discontinuation of omalizumab.

Key Dates

Start date

Feb 29, 2016

Status verified

Apr 2018

Primary completion

Dec 31, 2018

Completion

Dec 31, 2019

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: High Dose Vitamin D
  Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.
• Active Comparator: Low Dose Vitamin D
  Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.

Primary Outcome Measure

Change in total Urticaria Severity Score (USS) [ Time Frame: Change from Baseline to Month 6 ]

Locations (1)

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