NCT01087710

Brief Summary

To determine the effect of medical food on reducing asthma symptoms in asthmatic children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Jul 2004

Typical duration for phase_2 asthma

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

July 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

Enrollment Period

1.4 years

First QC Date

March 8, 2010

Last Update Submit

March 15, 2010

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • asthma free days

    12 weeks

Secondary Outcomes (4)

  • reduction of airway hyper-responsiveness

    12 weeks

  • time to the first asthma exacerbation

    12 weeks

  • respiratory function (spirometry)

    12 weeks

  • need for rescue for exacerbations of asthma symptoms.

    12 weeks

Study Arms (2)

novel nutritional formula

EXPERIMENTAL
Other: medical food with EPA and GLA, vitamins and minerals

Control nutritional product

ACTIVE COMPARATOR

1 8oz serving per day for 12 weeks

Other: medical food minus EPA and GLA, antioxidant vitamins/minerals

Interventions

medical food with EPA and GLA, vitamins and mineralsOTHER

1 8oz serving per day for 12 weeks

novel nutritional formula
medical food minus EPA and GLA, antioxidant vitamins/mineralsOTHER

1 8oz serving a day for 12 weeks

Control nutritional product

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible.
  • Each subject also has to have:
  • Subject is off of controller therapy 4 wks preceding visit 1.
  • Mild to moderate persistent asthma
  • Methacholine responsiveness with an FEV1 PC20
  • Able to perform reproducible spirometry
  • Verbal assent in addition to consent
  • History of prior clinical varicella or varicella vaccine.
  • Nonsmoker in past year.

You may not qualify if:

  • Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period.
  • Subject with FEV1 \< 80% predicted at visit 1 or FEV1 \< 70% predicted at visit 2.
  • Two or more hospitalizations for asthma in the past year.
  • Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month.
  • Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1
  • Subject is receiving one or more of the following medications:
  • Astemizole prior to 3 months of visit 1
  • Oral, inhaled or parenteral corticosteroids prior to 4 weeks of visit 1
  • Cromolyn, antimuscarinics, cimetidine, metoclopramide, phenobarbital, phenytion, terfenadine, loratadine, or anticholingeric agents prior to 2 weeks of visit 1.
  • Theophylline prior to 4 weeks of visit 1
  • Subject with active upper respiratory tract infection prior to 4 weeks before visit 1
  • Subject with acute sinus disease requiring antibiotic treatment within 1 week before visit
  • Subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months
  • Subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects.
  • Subject has known hypersensitivity to any of the ingredients
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

  • Covar R, Gleason M, Macomber B, Stewart L, Szefler P, Engelhardt K, Murphy J, Liu A, Wood S, DeMichele S, Gelfand EW, Szefler SJ. Impact of a novel nutritional formula on asthma control and biomarkers of allergic airway inflammation in children. Clin Exp Allergy. 2010 Aug;40(8):1163-74. doi: 10.1111/j.1365-2222.2010.03523.x. Epub 2010 Jun 7.

    PMID: 20545703DERIVED

MeSH Terms

Conditions

Asthma

Interventions

gamma-carboxyglutamyl-gamma-carboxyglutamic acidVitaminsMinerals

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesInorganic Chemicals

Study Officials

  • Stehen DeMichele, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 16, 2010

Study Start

July 1, 2004

Primary Completion

December 1, 2005

Study Completion

January 1, 2006

Last Updated

March 16, 2010

Record last verified: 2010-03

Locations

US(1)