Vitamin D Supplementation in Childhood Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos A. Camargo, Jr., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00879424
First received: April 9, 2009
Last updated: December 16, 2013
Last verified: December 2013

April 9, 2009
December 16, 2013
February 2009
April 2009   (final data collection date for primary outcome measure)
  • EASI score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Investigator Global Assessment (IGA) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00879424 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Vitamin D Supplementation in Childhood Atopic Dermatitis
Randomized Trial of Vitamin D Supplementation in Winter-related, 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • Dietary Supplement: cholecalciferol (vitamin D)

    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.
  • Dietary Supplement: Placebo

    1000 IU once daily x 1 month

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

  • Experimental: 1
    Intervention: Dietary Supplement: cholecalciferol (vitamin D)
  • Placebo Comparator: 2
    Intervention: Dietary Supplement: Placebo
Sidbury R, Sullivan AF, Thadhani RI, Camargo CA Jr. Randomized controlled trial of vitamin D supplementation for winter-related atopic dermatitis in Boston: a pilot study. Br J Dermatol. 2008 Jul;159(1):245-7. Epub 2008 Jul 1. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Mongolia
 
NCT00879424
CeDAR-01
No
Carlos A. Camargo, Jr., Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Carlos A. Camargo, MD, DrPH Massachusetts General Hospital
Massachusetts General Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP