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
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Dietary Supplement: cholecalciferol (vitamin D)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • EASI score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Investigator Global Assessment (IGA) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Placebo Comparator: 2 Dietary Supplement: Placebo

1000 IU once daily x 1 month

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


  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879424

Locations
Mongolia
National Dermatology Center
Ulaan Baatar, Mongolia
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Carlos A. Camargo, MD, DrPH Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Carlos A. Camargo, Jr., Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00879424     History of Changes
Other Study ID Numbers: CeDAR-01
Study First Received: April 9, 2009
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
vitamin D
atopic dermatitis
eczema
winter

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 15, 2014