CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
High Dose Vitamin D3 +1 moredrug
Likely dose
High Dose Vitamin D3 4000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01371877
NCT01371877N/ACompleted

The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment

University of Nebraska·interventional·Posted Jun 13, 2011·Updated Sep 21, 2023

In Brief

A clinical study evaluating High Dose Vitamin D3 and Low Dose Vitamin D3 for Urticaria and 3 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This clinical study was designed based on our hypothesis that vitamin D plays an important role in chronic urticaria and that high dose supplementation with vitamin D in subjects with chronic urticaria will improve clinical response. This clinical study will investigate our hypothesis in three Specific Aims: 1. Determine whether high dosing vitamin D supplementation (4000 IU/day) reduces medication usage (primary outcome) and urticaria severity score (secondary outcome) in subjects with chronic urticaria as compared to low dosing (600 IU/day). 2. Determine if high dosing of vitamin D (4000 IU/day) is safe and well-tolerated in subjects with chronic urticaria with or without baseline vitamin D deficiency. 3. Investigate whether there is an association with serum 25-hydroxyvitamin D levels, vitamin D receptor mRNA expression, and chronic urticaria severity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2011
Enrollment StartNov 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.1 years ago

Interventions

High Dose Vitamin D3drug

Vitamin D 4000 IU per day for 3 months

Low Dose Vitamin D3drug

Vitamin D 600 IU per day