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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in SCORAD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Stoss vitamin D
Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)
干预措施: Stoss vitamin D (Drug)
Stoss vitamin D
Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)
干预措施: Daily placebo (Drug)
Daily vitamin D
Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)
干预措施: Daily vitamin D (Drug)
Daily vitamin D
Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)
干预措施: Stoss placebo (Drug)
Placebo
Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)
干预措施: Stoss placebo (Drug)
Placebo
Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)
干预措施: Daily placebo (Drug)
结局指标
主要结局
Change in SCORAD
时间窗: Change from baseline at 3 months
Atopic dermatitis severity score (SCORAD)
次要结局
- Effects on Parameters of bone metabolism (urine)(Baseline, 1 month and 3 months)
- Quality of life (family)(Baseline and 3 months)
- Adverse events(Throughout the study period, an average of 3 months)
- Effects on Parameters of bone metabolism (serum)(Baseline and 3 months)
- Immunoglobulin E (IgE) (serum)(Baseline and 3 months)
- Quality of life (child)(Baseline and 3 months)
- Compliance to study medications(Throughout the study period, , an average of 3 months)
- Vitamin D polymorphisms(Baseline)
- SCORAD(At 3 months)
- Vitamin D levels(Baseline and 3 months)