Vitamin D Supplementation in Childhood Atopic Dermatitis

Mass General Brigham

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: cholecalciferol (vitamin D)

Study type: Interventional

Funder types: Other

Identifiers

NCT00879424

CeDAR-01

Details and patient eligibility

About

The goal of this clinical trial is to investigate the therapeutic role of vitamin D supplementation in a subset of patients with atopic dermatitis (AD): children with disease onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D supplementation in patients with either wintertime onset or exacerbation of AD will improve Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve the Investigator's Global Assessment.

Enrollment: 107 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 2-17 years
• AD rated 10-72 by EASI scale
• Wintertime onset or exacerbation of AD

Exclusion criteria

• Active skin infection
• History of summertime onset or exacerbation of AD
• History of underlying illness causing immunosuppression within the past 2 years (eg. hematologic malignancies)
• Medications causing iatrogenic immunosuppression (eg. cyclosporine; azathioprine, oral steroids) taken within the past month
• Parathyroid disease
• Acute or chronic renal disease
• Hypercalcemia or hypocalcemia
• Thyroid disease
• History of osteomalacia or Paget's disease of bone
• History of malabsorption (eg cystic fibrosis)
• Planned trip to sunny climate during the one-month study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Dietary Supplement: cholecalciferol (vitamin D)

2

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo