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

Atopic Dermatitis Clinical Trial

— D-Vex  

Official title:

A Phase IV, Double-blind, Randomised, Placebo-controlled Trial to Assess the Efficacy and Safety of Stoss Versus Daily Dose Oral Vitamin D Compared to Placebo for the Treatment of Atopic Dermatitis in Pre-school Aged Children- a Pilot Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03257215
• Other study ID #: HREC 36237
• Status: Suspended
• Phase: Phase 4
• Start date: October 16, 2017
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Stoss vitamin D
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. )
• Daily vitamin D
Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90
• Stoss placebo
A single 1.5 mL dose administered on Day 1
• Daily placebo
A once daily 0.2 mL dose administered from Day 1 to 90

Locations

Country	Name	City	State
Australia	Royal Children's Hospital Melbourne	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SCORAD	Atopic dermatitis severity score (SCORAD)	Change from baseline at 3 months
Secondary	Vitamin D levels	vitamin D level in serum	Baseline and 3 months
Secondary	Vitamin D polymorphisms	Presence of defined vitamin D polymorphisms	Baseline
Secondary	Immunoglobulin E (IgE) (serum)	Serum	Baseline and 3 months
Secondary	Effects on Parameters of bone metabolism (serum)	Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase	Baseline and 3 months
Secondary	Effects on Parameters of bone metabolism (urine)	Calcium:Creatinine (urine)	Baseline, 1 month and 3 months
Secondary	Quality of life (family)	Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)	Baseline and 3 months
Secondary	Quality of life (child)	Standardised questionnaire: Child Dermatology Life Quality Index (CDLQI) if >= 4 years of age OR Infant Dermatology Quality of Life (IDQOL) if <4 years of age	Baseline and 3 months
Secondary	Compliance to study medications	Vitamin D stoss/daily and placebo stoss/daily	Throughout the study period, , an average of 3 months
Secondary	Adverse events	Serious adverse events and serious adverse events	Throughout the study period, an average of 3 months
Secondary	SCORAD	Atopic dermatitis severity score (SCORAD)	At 3 months