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Completed

NCT Number: NCT00879424

Vitamin D Supplementation in Childhood Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Dermatology Center

Ulaanbaatar, Mongolia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Experimental group will receive Ddrops (Toronto, Canada)., Placebo group will receive placebo drops.

Placebo

Dietary Supplement

1000 IU once daily x 1 month

Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.

Primary outcomes

  1. EASI score

    Time frame: 1 month

  2. Investigator Global Assessment (IGA)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 10, 2009
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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