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Vitamin D Supplementation in Childhood Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Mongolia
Study Type
Interventional
Intervention
cholecalciferol (vitamin D)
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring vitamin D, atopic dermatitis, eczema, winter

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Dermatology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

EASI score
Investigator Global Assessment (IGA)

Secondary Outcome Measures

Full Information

First Posted
April 9, 2009
Last Updated
December 20, 2016
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00879424
Brief Title
Vitamin D Supplementation in Childhood Atopic Dermatitis
Official Title
Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
vitamin D, atopic dermatitis, eczema, winter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol (vitamin D)
Other Intervention Name(s)
Experimental group will receive Ddrops (Toronto, Canada)., Placebo group will receive placebo drops.
Intervention Description
1000 IU once daily x 1 month Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1000 IU once daily x 1 month Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.
Primary Outcome Measure Information:
Title
EASI score
Time Frame
1 month
Title
Investigator Global Assessment (IGA)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos A. Camargo, MD, DrPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Dermatology Center
City
Ulaan Baatar
Country
Mongolia

12. IPD Sharing Statement

Citations:
PubMed Identifier
18489598
Citation
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.
Results Reference
background
PubMed Identifier
25282565
Citation
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.
Results Reference
result
PubMed Identifier
33305842
Citation
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.
Results Reference
derived

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Vitamin D Supplementation in Childhood Atopic Dermatitis

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