NCT01366222

Brief Summary

The purpose of this study is to determine whether food concentrates supplementation (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma symptoms and lung function in children due to asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
Last Updated

June 6, 2011

Status Verified

June 1, 2011

Enrollment Period

1.3 years

First QC Date

May 25, 2011

Last Update Submit

June 2, 2011

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

  • The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points

    Baseline, 8 weeks and 16 weeks after intervention

Secondary Outcomes (4)

  • The change of pulmonary functions (FVC, FEV1) at three time points

    Baseline, 8weeks and 16 weeks after intervention

  • The change of medicine usage at three time points

    Baseline, 8 weeks and 16 weeks after intervention

  • The change of asthma control test score(ACT) at three time points

    Baseline, 4, 8,12 and 16 weeks after intervention

  • weekly diary

    Baseline and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 weeks after intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics

Food concentrates (FC)

ACTIVE COMPARATOR

Food concentrates (FC) was including fruit and vegetable, fish and probiotics.

Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics

Interventions

food concentrates: fruit, vegetable, fish oil and probioticsDIETARY_SUPPLEMENT

comparison the effect of food concentrate

Also known as: fruit and vegetable concentrates, fish oil, probiotics
Food concentrates (FC)Placebo

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of asthma

You may not qualify if:

  • subjects received immunotherapy over the past 6 months
  • Long-term used oral corticosteroids
  • have other diseases such as heart disease, kidney disease, liver abnormalities
  • have been supplement fish oil, probiotics, and high levels of vitamin supplements in the past three months
  • vegetarian
  • subjects have hemorrhagic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academia Sinica

Taipei, 115, Taiwan

Location

MeSH Terms

Conditions

Asthma

Interventions

VegetablesFish OilsProbioticsFruit

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesOilsLipidsDietary Supplements

Study Officials

  • Wen-Han Pan, Ph. D.

    Academia Sinica, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 6, 2011

Study Start

November 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 6, 2011

Record last verified: 2011-06

Locations

TW(1)