Allergic Bronchial Asthma Clinical Trial
Official title:
Pilot Study on the Effects of Oral Intervention With c9,t11-conjugated Linoleic Acid in Children and Adolescents With Allergic Asthma
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00890734 -
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
|
Phase 2 |