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Vitamin D Supplementation in Childhood Atopic Dermatitis

Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00879424
Enrollment
107
Registered
2009-04-10
Start date
2009-02-28
Completion date
2009-05-31
Last updated
2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

vitamin D, atopic dermatitis, eczema, winter

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTcholecalciferol (vitamin D)

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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
EASI score1 month
Investigator Global Assessment (IGA)1 month

Countries

Mongolia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026