Vitamin D Deficiency and Atopic Dermatitis
Primary Purpose
Atopic Dermatitis, Vitamin D Deficiency
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Serum 25-hydroxyvitamin D level <20 ng/ml (<50 nmol/L)
- Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
- Age 1-18 years old
- Primary residence in Milwaukee County
- Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis [SCORAD] score greater than 15)
- On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)
Sites / Locations
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard dose vitamin D
High dose vitamin D
Arm Description
Treatment with cholecalciferol 400 IU daily at home.
Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Outcomes
Primary Outcome Measures
Atopic Dermatitis Severity at the Completion of Treatment
SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).
Secondary Outcome Measures
Time to Restart Topical Steroids
The time to restart topical steroids.
Full Information
NCT ID
NCT01337635
First Posted
November 3, 2010
Last Updated
November 7, 2018
Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT01337635
Brief Title
Vitamin D Deficiency and Atopic Dermatitis
Official Title
Treatment Of Vitamin D Deficiency And Effect On Atopic Dermatitis Severity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Not meeting enrollment goals.
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard dose vitamin D
Arm Type
Active Comparator
Arm Description
Treatment with cholecalciferol 400 IU daily at home.
Arm Title
High dose vitamin D
Arm Type
Active Comparator
Arm Description
Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Primary Outcome Measure Information:
Title
Atopic Dermatitis Severity at the Completion of Treatment
Description
SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Time to Restart Topical Steroids
Description
The time to restart topical steroids.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Serum 25-hydroxyvitamin D level <20 ng/ml (<50 nmol/L)
Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
Age 1-18 years old
Primary residence in Milwaukee County
Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis [SCORAD] score greater than 15)
On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Chiu, MD
Organizational Affiliation
Children's Hospital and Health System Foundation, Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Deficiency and Atopic Dermatitis
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