c9,t11-CLA in Children and Adolescents With Allergic Asthma

Not Applicable

Completed

• Conditions: Allergic Bronchial Asthma

• Registration Number: NCT01026506
• Lead Sponsor: University of Jena

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-12
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Last Update Submitted: 2009-12-03
• Study First Posted: 2009-12-04
• Last Update Posted: 2009-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
lung function parameters	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Jena, Institute of Nutrition, Department of Nutritional Physiology; 🇩🇪 Jena, Thuringia, Germany