Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,739
- 试验地点
- 1
- 主要终点
- The occurrence of definite food allergy or tolerance at 6 years of age
研究概览
简要总结
We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.
详细描述
There is an urgent need to prevent the onset and progression of food allergy in our population. Evidence demonstrates that food allergy and atopic eczema represent the earliest manifestations of the atopic march with 50% of infants with food allergy predicted to develop respiratory allergic diseases later in life. We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI), and have demonstrated an association between VDI and increased risk of challenge-proven food allergy in 12-month old infants, which supports numerous ecological studies showing an increased risk of food allergy the further a child resides from the equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's sunny climate, population rates of VDI have steadily increased in infants and pregnant women in parallel to the apparent rise in food allergic disease. This association is biologically plausible, as there is evidence Vitamin D is critical to the healthy development of the immune system in early life. We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each participant must meet the following criteria to be included in this study:
- •Healthy, term (born no earlier than 2 weeks before estimated date of delivery), predominantly breastfeeding infants aged 6 to 12 weeks (inclusive) who are expected to be predominantly breastfed for at least 6-months. This will be determined by answering yes/no to question 'do you intend/wish to breastfeed until your infant is at least 6 months of age.' Up to one bottle (approx. 120mL) of formula per 24 hours at the time of screening is acceptable, as this will contain <100 IU vitamin D.
- •Has a parent/legally acceptable representative (LAR) capable of understanding the informed consent document and providing consent on the subject's behalf,
- •The parent must expect to be able to complete 4 online questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing (+/- food challenge) at The Royal Children's Hospital at 12 months of age.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •Infants who are currently receiving vitamin D supplementation
- •Infants on medication that interferes with vitamin D metabolism
- •Poor health due to a current or past significant disease state or congenital abnormality.
- •Prematurity <37 weeks/low birth weight <2500 g/Small for gestational age (SGA)
- •Unable to provide consent without the aid of an interpreter.
- •Women at high risk of vitamin D deficiency with infants on vitamin D supplementation.
研究组 & 干预措施
vitamin D
400 IU /daily cholecalciferol/vitamin D
干预措施: Vitamin D (Drug)
placebo
carrier formulation minus vitamin D
干预措施: placebo (Drug)
结局指标
主要结局
The occurrence of definite food allergy or tolerance at 6 years of age
时间窗: At 6 years of age
The occurrence of definite food allergy or tolerance at 6 years of age can only be determined by combining data from an oral food challenge, a skin prick test (SPT) and/or serum specific IgE test, and/or parent/self-reported ingestion history and reactions to the index food.
The prevalence of challenge-proven food allergy at 12 months of age
时间窗: At 12 months of age
The prevalence of challenge-proven food allergy at 12 months of age determined by a positive SPT and a positive oral food challenge
次要结局
- The prevalence of food sensitisation at 12 months of age determined by SPT positive(At 12 months of age)
- The prevalence of doctor diagnosed eczema during the first postnatal year(During the first postnatal year)
- The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit(At 12 months of age)
- Allergy-related healthcare utilisation within the first 12 months of life(Within the first 12 months of life)
- Infection episodes within the first 12 months of life(Within the first 12 months of life)
- Measure of height at 12 months of age(At 12 months of age)
- Measure of weight at 12months of age(At 12 months of age)
- Wheeze episodes within the first 12 months of life(Within the first 12 months of life)
- The occurrence of food sensitisation at 6 years of age determined by SPT positive(At 6 years of age)
- The occurrence of asthma in the first 6 years of life(At 6 years of age)
- The occurrence of eczema in the first 6 years of life(Within first 6 years of life)
- The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 6 years determined by measuring blood taken at the 6 year clinic visit(At 6 years of age)
- Allergy-related healthcare utilisation in the first 6 years of life(Within first 6 years of life)
- Measure of height at 6 years of age(At 6 years of age)
- Measure of Waist circumference at 6 years of age(At 6 years of age)
- Measure of Hip circumference at 6 years of age(At 6 years of age)
- Lung function at 6 years of age(At 6 years of age)
- The occurrence of rhinitis in the first 6 years of life(Within first 6 years of life)
- Psychosocial Distress at 6 years of age(At 6 years of age)
- Psychosocial health at 6 years of age(At 6 years of age)
- Quality of life at 6 years of age(At 6 years of age)
- Quality of life regarding Food Allergy at 6 years of age(At 6 years of age)
- Dental health at 6 years of age(At 6 years of age)