The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Metabolomics Study of PUFA
研究概览
简要总结
This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman is pregnant between 16 and 20 weeks
- •Mother delivers after 36 weeks
- •Mother is willing to breast-feed for four months
- •Mother has potential to deliver a child with increased risk of atopic dermatitis
- •Signed Informed Consent
排除标准
- •Mother is smoking
- •Disease with influence on breast feeding
- •Complicated pregnancy
- •Allergic to seafood
- •Allergic to soy
- •Allergic to marine fish
- •Mother has more than two salmon or tuna meals per week
- •Mother is undergoing treatment with anticoagulants
研究组 & 干预措施
High Olive Oil
infants receiving capsule without DHA and EPA.
干预措施: High Olive Oil (Dietary Supplement)
DHA+EPA
infants receiving capsule containing DHA and EPA.
干预措施: DHA+EPA (Dietary Supplement)
Docosahexaenoic Acid (DHA)
infants receiving capsule containing DHA.
干预措施: DHA (Dietary Supplement)
结局指标
主要结局
Metabolomics Study of PUFA
时间窗: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum
Lipid Analysis
时间窗: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum
Skin Prick Test to Common Allergens
时间窗: 4 months postpartum, 12 months postpartum
Clinical Assessment of IgE-mediated Allergic Eczema
时间窗: 4 months postpartum, 12 months postpartum
次要结局
- Fatty Acid Desaturase (FADS) Genotypes(Baseline)
- immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies(Baseline)
- Medically-confirmed adverse events collected throughout the study period(12 months postpartum)
- Immunological Biomarkers(4 months postpartum, 12 months postpartum)