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CompletedNCT00879424Updated Dec 22, 2016

Vitamin D Supplementation in Childhood Atopic Dermatitis

An interventional study of cholecalciferol (vitamin D) and Placebo in Atopic Dermatitis, sponsored by Massachusetts General Hospital. Completed at 1 site in Mongolia. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-12-22.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • vitamin D
  • atopic dermatitis
  • eczema
  • winter
03

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 2-17 years
  • AD rated 10-72 by EASI scale
  • Wintertime onset or exacerbation of AD

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    1

    Dietary Supplement: cholecalciferol (vitamin D)

  • Placebo comparator
    2

    Dietary Supplement: Placebo

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.

    Also known as: 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.

05

What researchers measure

Primary outcomes

  1. EASI score

    Time frame: 1 month

  2. Investigator Global Assessment (IGA)

    Time frame: 1 month

06

Study locations

1 site
  • National Dermatology Center
    Ulaan Baatar, Mongolia
07

References and documents

Publications

  • 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. doi: 10.1111/j.1365-2133.2008.08601.x. Epub 2008 Jul 1. No abstract available. PubMed 18489598 ↗
  • Camargo CA Jr, Ganmaa D, Sidbury R, Erdenedelger Kh, Radnaakhand N, Khandsuren B. Randomized trial of vitamin D supplementation for winter-related atopic dermatitis in children. J Allergy Clin Immunol. 2014 Oct;134(4):831-835.e1. doi: 10.1016/j.jaci.2014.08.002. PubMed 25282565 ↗
  • Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2. PubMed 33305842 ↗
08

Registry details

Key details

Study ID
NCT00879424
Lead sponsor
Massachusetts General Hospital
Responsible party
Carlos A. Camargo, Jr. (Physician, Massachusetts General Hospital) — Principal investigator
First posted
Apr 10, 2009
Start date
Feb 2009
Primary completion
Apr 2009
Completion
May 2009
Last update
Dec 22, 2016

Study contacts

Carlos A. Camargo, MD, DrPH
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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