NCT01026506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

Enrollment Period

11 months

First QC Date

December 3, 2009

Last Update Submit

December 3, 2009

Conditions

Allergic Bronchial Asthma

Keywords

c9,t11-CLAallergic bronchial asthmachildren and adolescents

Outcome Measures

Primary Outcomes (1)

  • lung function parameters

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Interventions

conjugated linoleic acidDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • Jaudszus A, Mainz JG, Pittag S, Dornaus S, Dopfer C, Roth A, Jahreis G. Effects of a dietary intervention with conjugated linoleic acid on immunological and metabolic parameters in children and adolescents with allergic asthma--a placebo-controlled pilot trial. Lipids Health Dis. 2016 Feb 3;15:21. doi: 10.1186/s12944-016-0187-6.

    PMID: 26843092DERIVED

MeSH Terms

Interventions

Linoleic Acids, Conjugated

Intervention Hierarchy (Ancestors)

Linoleic AcidsFatty Acids, Omega-6Fatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    University of Jena, Dept. of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations

DE(1)