Vitamin D Supplementation in Childhood Atopic Dermatitis

Massachusetts General Hospital107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

107

Conditions

Atopic Dermatitis

Interventions

cholecalciferol (vitamin D)DIETARY_SUPPLEMENT

1000 IU once daily x 1 month Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.

PlaceboDIETARY_SUPPLEMENT

1000 IU once daily x 1 month Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

National Dermatology Center

Ulaanbaatar, Mongolia

Outcomes

Primary Outcomes

EASI score

Time frame: 1 month

Investigator Global Assessment (IGA)

Time frame: 1 month

Data from ClinicalTrials.gov

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