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NCT01371877 · ClinicalTrials.gov registry record · NA
The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment
A NA study, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT01371877: Completed NA study, sponsored by University of Nebraska.
NCT01371877 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01371877, a NA study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
The Unit of Measure is Efficacy. The primary outcome of this study is to determine if vitamin D supplementation reduces the medication usage in subjects with CUA. Thus, for the outcome of reduction in pills, at 12 weeks, subjects whose pill usage decreases by 2 or more pills per day will be classified as improved. Subjects whose pill consumption did not change or increased will be classified as unchanged.
Interventions
- DRUG High Dose Vitamin D3
- DRUG Low Dose Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-11-01 |
| Est. Completion | 2013-09-01 |
| Phase | NA |
What the finished NCT01371877 record still lists
NCT01371877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which High Dose Vitamin D3 is the first listed.
NCT01371877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01371877 about?
NCT01371877 is a clinical study titled "The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment". 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 Spec...
What is the current status of trial NCT01371877?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2011-11-01. Estimated completion is 2013-09-01.
What interventions are being tested in trial NCT01371877?
The interventions under investigation include: High Dose Vitamin D3 (DRUG), Low Dose Vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT01371877?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01371877's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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