跳至主要内容
临床试验/NCT01026506
NCT01026506已完成不适用

Pilot Study on the Effects of Oral Intervention With c9,t11-conjugated Linoleic Acid in Children and Adolescents With Allergic Asthma

University of Jena2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
lung function parameters

研究概览

简要总结

The study was performed to investigate the effects of a dietary intervention with c9,t11-CLA on clinical and immunological parameters in children and adolescents with allergic bronchial asthma.

详细描述

In-vitro and animal studies strongly suggest that c9,t11-CLA reduces inflammatory processes in asthma-models. Aim of this study was to determine possible beneficial effects of orally administered c9,t11-CLA in children and adolescents with allergic bronchial asthma.

Thirty subjects (14 girls, 16 boys, age 6-18 years) were recruited from regular patients in the Clinic for Pediatric Allergology of the Friedrich Schiller University Jena. Informed consent was obtained from all participants/parents. 29 subjects completed the study.

The study was designed as a randomized and placebo-controlled study. After a 1-week run-in period to ascertain the current state of disease and categorization of allergic sensitization by RAST, the participants were randomized and evenly distributed to receive either 3 g/d of an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or 3 g/d of a placebo oil mixed in 100 g portions of milk fat-free yoghurt for 12 weeks. The yoghurt was freshly prepared and distributed in frequent intervals.

At the beginning and at the end of the study, lung function parameters were assessed by whole body plethysmography, and venous blood and 24h-urine samples were collected for further analyses. Throughout the entire study, the participants daily recorded their peak-flow data and kept protocol about their symptoms and drug usage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 6-18 years
  • doctor-diagnosed bronchial asthma
  • allergic sensitization (house dust mite, grass pollen)
  • willingness to use only the recommended drugs
  • competence regarding the daily documentation of peak-flow data and symptoms

排除标准

  • SIT within the last 2 years
  • primary and secondary immune deficiency
  • usage of systemic corticoids
  • intolerance against milk protein
  • alcohol and drug abuse

结局指标

主要结局

lung function parameters

时间窗: 12 weeks

次要结局

  • symptom score, serum ECP, ex-vivo and in-vitro cytokine production of PBMC, urinary oxidation parameters, fatty acid distribution in erythrocytes(12 weeks)

研究者

发起方
University of Jena
申办方类型
Other

研究点 (2)

Loading locations...

相似试验