Can Vitamin D Treatment Help Treat Moderate to Severe Ato... | NCT03257215

Studies
Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study

NCT03257215

Sponsor

Murdoch Childrens Research Institute

Status

Terminated

Last Update Posted

Mar 14, 2025Actual

Enrollment

13Actual

Phase

Phase 4

Conditions

Atopic Dermatitis

Interventions

Stoss vitamin D
Daily vitamin D
Stoss placebo
Daily placebo

Countries

Australia

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment very slow & ongoing funding not obtained.

Expanded Access Info

Start Date

Oct 16, 2017Actual

Primary Completion Date

Jan 30, 2025Actual

Completion Date

Jan 30, 2025Actual

First Submitted Date

Aug 13, 2017

First Submission Date that Met QC Criteria

Aug 17, 2017

First Posted Date

Aug 22, 2017Actual

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

Mar 11, 2025

Last Update Posted Date

Mar 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Vitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D as a treatment for AD are limited in number and size. There has never been a placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway genes and response to treatment of AD. This pilot study will be used as a reference to determine outcomes and feasibility for undertaking a larger and more in depth definitive study.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stoss vitamin D	Active Comparator	Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)	Drug: Stoss vitamin D Drug: Daily placebo
Daily vitamin D	Active Comparator	Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)	Drug: Daily vitamin D Drug: Stoss placebo
Placebo	Placebo Comparator	Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)	Drug: Stoss placebo Drug: Daily placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stoss vitamin D	Drug	A single 1.5 mL dose containing 150,000 IU cholecalciferol (100,000 IU/mL) administered on Day 1 (Solution in Olive Oil B.P. )	Stoss vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in SCORAD	Atopic dermatitis severity score (SCORAD)	Change from baseline at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Vitamin D levels	vitamin D level in serum	Baseline and 3 months
Vitamin D polymorphisms	Presence of defined vitamin D polymorphisms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

moderate to severe atopic dermatitis with a SCORAD ≥ 20 at baseline.
aged between 1 ≤ 12 years of age at the time of randomisation.
regularly ingest the recommended dietary intake (RDI) of calcium and plan to do so for the next 3 months
have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

use of vitamin D supplementation, including a stoss dose of vitamin D in the previous year, or daily supplementation in the past month
drink vitamin D fortified formula (all formulas) as the main milk intake
received oral steroids within the past 6 months
received oral immunosuppression in the past (cyclosporine, azathioprine, methotrexate)
received UV therapy in the past 12 months
have been fully formula fed within the past 6 months
ave renal or liver or gastrointestinal (e.g.: coeliac, inflammatory bowel disease) disease
receiving thiazide-type diuretics or anticonvulsant therapy
have ever been diagnosed with Hypercalcaemia, Hypertension or Rickets
unable to provide consent without the aid of an interpreter
in the opinion of the Investigator, are unable to follow the protocol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kirsten P Perrett, MBBS	Murdoch Childrens Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Royal Children's Hospital Melbourne		Melbourne	Victoria	3052	Australia

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided