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

This study has been completed.
Sponsor:
Collaborator:
Cognis GmbH & Co. KG
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01026506
First received: December 3, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Allergic Bronchial Asthma
Dietary Supplement: conjugated linoleic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study on the Effects of Oral Intervention With c9,t11-conjugated Linoleic Acid in Children and Adolescents With Allergic Asthma

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • lung function parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • symptom score, serum ECP, ex-vivo and in-vitro cytokine production of PBMC, urinary oxidation parameters, fatty acid distribution in erythrocytes [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026506

Locations
Germany
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Cognis GmbH & Co. KG
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. University of Jena, Dept. of Nutritional Physiology
  More Information

No publications provided

Responsible Party: Prof. Dr. G. Jahreis, University of Jena, Dept. of Nutritional Physiology
ClinicalTrials.gov Identifier: NCT01026506     History of Changes
Other Study ID Numbers: LSEP H34-08
Study First Received: December 3, 2009
Last Updated: December 3, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
c9,t11-CLA
allergic bronchial asthma
children and adolescents

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014