Optimizing Vitamin D Status in Children With Pre-school Wheeze or Asthma:a Pilot Study (OPTIVIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of children with vitamin D status above or equal to 75 nmol/L at 3 and 6 months of oral vitamin D3 supplementation
研究概览
简要总结
Vitamin D deficiency is highly prevalent in the UK. Research shows that vitamin D enhances the immune system and may help protect against chest infections that can cause wheezing illness or worsen asthma symptoms. The Department of Health recommends a dose of 10 micrograms of vitamin D/day to prevent severe vitamin D deficiency in children. However, many studies have reported that this dose is not enough to raise plasma 25(OH)D concentration to the levels most likely to prevent against worsening of asthma symptoms. Such studies suggest that 25 micrograms of vitamin D/day. This dose is safe but its effects on vitamin D blood levels have not yet been specifically tested in children with asthma/wheeze. This study is designed to determine the optimal oral daily vitamin D supplementation dose to treat vitamin D deficiency in children with asthma or preschool wheeze. Over the 6-month course of the study, participants will meet with the study team four times in clinic or in their own home and will be contacted by telephone five times. Children will be asked to give a drop of blood via a fingerprick to test their vitamin D level and a sample of nasal epithelial lining fluid for measurement of inflammatory markers on three separate occasions.
详细描述
The study is designed to compare the efficacy of a daily oral vitamin D3 supplementation dose of 10 micrograms (400 IU) for 3 months vs a daily oral vitamin D3 supplementation dose of 25 micrograms (1,000 IU) for an additional 3 months in correcting vitamin D deficiency in children with asthma or preschool wheezing illness.
Identification procedures
A member of the patient's usual care team will identify potentially eligible participants from patient records at participating sites. Identified individuals will be contacted by post, giving a brief explanation of the study and asking them to contact a member of the research team if they wish to find out more. A member of the research team will explain the study to them and ask them if they would like to receive the study participant information sheet (PIS). The PIS will be posted to patients expressing an interest in the study; those who subsequently confirm their interest in participation will be re-contacted by the study team, and offered a screening appointment at a study site. Additionally, posters advertising the study and providing contact details for the study team will be displayed in appropriate public places, such as hospital out-patient departments and General Practitioner (GP) surgeries, where potentially eligible participants are likely to see them; advertisements for the study may also be placed in the press, and circulated on email within Queen Mary, University of London. Potentially eligible children who fulfill eligibility criteria and give their assent (if aged ≥7 years) and have consent from their parent/legal guardian will be enrolled in the study.
Study visits
Visit 1 - Screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-12 years
- •For children aged 1-4 years: ≥2 self-reported wheezing illness episodes (as shown in a video recording of a wheeze episode) requiring unscheduled healthcare in the previous year
- •For children aged 5-12 years: doctor diagnosis of asthma and ≥1 self-reported asthma exacerbation requiring an unscheduled healthcare visit in the previous year.
- •Children's parent/legal guardian gives informed consent for children.
- •If child aged ≥7 years, gives informed assent.
排除标准
- •Baseline 25(OH)D concentration ≥75 nmol/L.
- •Already taking any vitamin D supplements.
- •Any other chronic or recent acute respiratory or systemic condition.
- •Already enrolled in another interventional research study
研究组 & 干预措施
Vitamin D supplement (Cholecalciferol)
Participants will be given oral Fultium-D3 drops (Internis) contain 400 IU cholecalciferol/day for a period of 3 months. Daily vitamin D3 supplementation dose will be increased to 1,000 IU for an additional 3 months if plasma 25(OH)D still below 75 nmol/L.
干预措施: Fultium-D3 drops (Internis) (Dietary Supplement)
结局指标
主要结局
Proportion of children with vitamin D status above or equal to 75 nmol/L at 3 and 6 months of oral vitamin D3 supplementation
时间窗: 6 months in total
Proportion of children with asthma and pre-school wheezing illness with baseline serum 25(OH)D concentration\<75 nmol/L attaining serum 25(OH)D concentration \>75 nmol/L after 3 months of an oral daily dose of 400 IU and after an additional 3 months of oral daily vitamin D3 supplementation with 1,000 IU
次要结局
- Changes from baseline in childhood Asthma Control Test at 3 and 6 months(6 months in total)
- Adherence to study supplement(6 months in total)
- Changes from baseline in concentration of inflammatory mediators in nasal epithelial lining fluid at 3 and 6 months after daily oral vitamin D3 supplementation(6 months in total)
- Proportion of children with treatment related adverse events D status at 3 and 6 months of oral vitamin D3 supplementation(6 months in total)
- Capture of unscheduled health care attendances for asthma or wheezing illness(6 months in total)
- Agreement between self-reported and GP record number of unscheduled healthcare visits(6 months in total)
- Capture of unscheduled health care attendances for asthma or wheezing illness (self-reported)(6 months in total)
- Determinants of vitamin D status(6 months in total)
- Participant's feedback about the study(6 months in total)