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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026506
• Other study ID #: LSEP H34-08
• Status: Completed
• Phase: N/A
• First received: December 3, 2009
• Last updated: December 3, 2009
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Bronchial Asthma
• Asthma

Intervention

Dietary Supplement:
• conjugated linoleic acid
3 g/d of an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or placebo oil mixed in yoghurt for 12 weeks

Locations

Country	Name	City	State
Germany	University of Jena, Institute of Nutrition, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	Cognis GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung function parameters		12 weeks	Yes
Secondary	symptom score, serum ECP, ex-vivo and in-vitro cytokine production of PBMC, urinary oxidation parameters, fatty acid distribution in erythrocytes		12 weeks	Yes