Vitamin D Supplementation in Childhood Atopic Dermatitis | NCT00879424

Studies
Vitamin D Supplementation in Childhood Atopic Dermatitis

NCT00879424

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Dec 22, 2016Estimated

Enrollment

107Actual

Phase

Not Applicable

Conditions

Atopic Dermatitis

Interventions

cholecalciferol (vitamin D)
Placebo

Countries

Mongolia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Apr 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Apr 9, 2009

First Submission Date that Met QC Criteria

Apr 9, 2009

First Posted Date

Apr 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2016

Last Update Posted Date

Dec 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Dietary Supplement: cholecalciferol (vitamin D)
2	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EASI score		1 month
Investigator Global Assessment (IGA)		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlos A. Camargo, MD, DrPH	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Dermatology Center		Ulaanbaatar			Mongolia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18489598	Background	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.
25282565	Result

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

ID	Term
D002762	Cholecalciferol
D014807	Vitamin D

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds