Atopic Dermatitis, Vitamin D Deficiency
Conditions
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.
Interventions
DRUGVitamin D
Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
Sponsors
Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atopic Dermatitis Severity at the Completion of Treatment | 6 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Restart Topical Steroids | 6 weeks | The time to restart topical steroids. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Dose Vitamin D Treatment with cholecalciferol 400 IU oral daily at home for 6 weeks | 3 |
| High Dose Vitamin D Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | High Dose Vitamin D | Standard Dose Vitamin D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5 years | 9 years | 6.7 years |
| Region of Enrollment United States | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
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).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Dose Vitamin D | Atopic Dermatitis Severity at the Completion of Treatment | 33.1 score on a scale |
| High Dose Vitamin D | Atopic Dermatitis Severity at the Completion of Treatment | 15.5 score on a scale |
Secondary
Time to Restart Topical Steroids
The time to restart topical steroids.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Dose Vitamin D | Time to Restart Topical Steroids | NA days |
| High Dose Vitamin D | Time to Restart Topical Steroids | NA days |