The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment

NCT01371877 | Completed Results

• 1 other identifier: 0271-11-FB
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Investigate whether there is an association with serum 25-hydroxyvitamin D levels, vitamin D receptor mRNA expression, and chronic urticaria severity.

Conditions

Urticaria; Angioedema; Hives; Swelling

Keywords

urticaria; angioedema; hive; swelling

Outcome Measures

Primary Outcomes (1)

• Medication Usage

  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.

  12 week intervention

Secondary Outcomes (2)

• Total Urticaria Severity Score at 3 Months

  3 month intervention

• Number of Participants With Adverse Events

  3 month study trial

Study Arms (2)

Vitamin D3 4000 IU

EXPERIMENTAL

Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months. Subjects will be given Vitamin D3 supplementation at 4000 IU daily.

Drug: High Dose Vitamin D3

Vitamin D3 600 IU

ACTIVE COMPARATOR

Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months. Subjects will be given Vitamin D3 supplementation at 600 IU daily

Drug: Low Dose Vitamin D3

Interventions

High Dose Vitamin D3 DRUG

Vitamin D 4000 IU per day for 3 months

Also known as: cholecalciferol

Vitamin D3 4000 IU

Low Dose Vitamin D3 DRUG

Vitamin D 600 IU per day

Also known as: cholecalciferol

Vitamin D3 600 IU

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be included if they have physician-diagnosed chronic urticaria and/or angioedema (CUA). CUA is defined by having urticarial wheals (hives) and/or angioedema (dermal swelling) on a daily or almost daily for more than 6 weeks. Patients with CUA also having signs of dermatographism and/or delayed-pressure urticaria will be included in the study. Subjects with history of intolerance to non-steroidal anti-inflammatory drugs will be included but warned not to take this drug class (acetaminophen will be allowed instead).

You may not qualify if:

• Subjects will be excluded if:
• They are not capable of answering the questionnaire.
• Subjects with a pure physical or allergic urticarias, and/or hereditary and acquired angioedema (C1 esterase inhibitor deficiency). These subjects will be excluded as the etiology of their disease is known.
• Pregnant or lactating women. All child-bearing women will be asked (verbally and on the questionnaire) if they are pregnant or lactating. If they answer yes, they will be excluded. As there is no risk or harm to the pregnant or lactating woman, a urine pregnancy test will not be used.
• Subjects with any clinically significant abnormality in biochemistry testing, and/or hypercalcemia (calcium \> 10.3 mg/dl) or renal insufficiency (GFR\< 50 ml/min).
• Subjects with a history of primary hyperparathyroidism, renal tubular acidosis, sarcoidosis, granulomatous disease, or malignancy.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (2)

• Thorp WA, Goldner W, Meza J, Poole JA. Reduced vitamin D levels in adult subjects with chronic urticaria. J Allergy Clin Immunol. 2010 Aug;126(2):413; author reply 413-4. doi: 10.1016/j.jaci.2010.04.040. No abstract available.

  PMID: 20621341 BACKGROUND

• Rorie A, Goldner WS, Lyden E, Poole JA. Beneficial role for supplemental vitamin D3 treatment in chronic urticaria: a randomized study. Ann Allergy Asthma Immunol. 2014 Apr;112(4):376-82. doi: 10.1016/j.anai.2014.01.010. Epub 2014 Feb 5.

  PMID: 24507460 DERIVED

MeSH Terms

Conditions

Urticaria; Angioedema

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Jill Poole
• Organization: University of Nebraska Medical Center

japoole@unmc.edu

402-559-4087

Study Officials

• Jill A Poole, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 13, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 21, 2023
• Results First Posted: December 16, 2014

Record last verified: 2023-09

Locations

US (1)