Trial · NCT01027143

Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids

NCT01027143, Phase 2, Phase 3, Completed, Nemours Children's Clinic; results first posted 2023-09-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids. Trials, record NCT01027143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01027143

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
NCT number: NCT01027143
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 143 participants, actual
Lead sponsor: Nemours Children's Clinic
Conditions: Asthma, Obesity
Interventions: omega-3 polyunsaturated fatty acids, Omega-3 Fatty Acid
First posted: 2009-12-07
Last updated: 2023-09-08
Results first posted: 2023-09-08

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Asthma Control Questionnaire (Juniper)	baseline, 3 months, 6 months	The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
Secondary	N3-to-n6 PUFA Ratio (Granulocytes)	Baseline, 3 and 6 months	Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood
Secondary	N3-to-n6 PUFA Ratio (Monocytes)	Baseline, 3 months, 6 months	Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood
Secondary	Asthma Control Test	Baseline, 3 months, 6 months	The asthma control test assesses patient reported symptoms from the prior month and has a range from 5 to 25 with a higher score suggesting better asthma control.
Secondary	Urinary Leukotriene-E4	Baseline, 3 months, 6 months	Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.
Secondary	FEV1	Baseline, 3 months, 6 months	Forced expiratory volume in 1 second is a validated spirometry measure.
Secondary	Exacerbations	6 months	Exacerbations of asthma were defined by the need for urgent medical care (emergency room or urgent care clinic) or systemic corticosteroids to avoid severe worsening of asthma determined by study physician or local provider
Secondary	Phone Contacts	6 months	Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Asthma Control Questionnaire (Juniper)	baseline, 3 months, 6 months		score on a scale	MEAN
SECONDARY	N3-to-n6 PUFA Ratio (Granulocytes)	Baseline, 3 and 6 months	Blood was not successfully drawn in all children	no units (ratio)	MEAN
SECONDARY	N3-to-n6 PUFA Ratio (Monocytes)	Baseline, 3 months, 6 months	blood was not successfully drawn in all children	no units (ratio)	MEAN
SECONDARY	Asthma Control Test	Baseline, 3 months, 6 months	missing data due to drop outs or staff error	units on a scale	MEAN
SECONDARY	Urinary Leukotriene-E4	Baseline, 3 months, 6 months	missing data resulted from participants lost to follow up or not providing urine samples	pg/mg creatinine	MEAN
SECONDARY	FEV1	Baseline, 3 months, 6 months	missing data due to participants lost to follow-up or not being able to provide valid spirometry	percent of predicted	MEAN
SECONDARY	Exacerbations	6 months	all randomized participants	exacerbations	NUMBER
SECONDARY	Phone Contacts	6 months	all randomized participants	events	NUMBER

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Asthma Control Questionnaire (Juniper)	Omega-3 Fatty Acids	Baseline	1.13	95% Confidence Interval 0.95 to 1.31	score on a scale
Asthma Control Questionnaire (Juniper)	Control	Baseline	1.08	95% Confidence Interval 0.78 to 1.39	score on a scale
Asthma Control Questionnaire (Juniper)	Omega-3 Fatty Acids	Change at 3 months	-0.08	95% Confidence Interval -0.25 to 0.08	score on a scale
Asthma Control Questionnaire (Juniper)	Control	Change at 3 months	-0.09	95% Confidence Interval -0.52 to 0.33	score on a scale
Asthma Control Questionnaire (Juniper)	Omega-3 Fatty Acids	Change at 6 months	-0.09	95% Confidence Interval -0.29 to 0.10	score on a scale
Asthma Control Questionnaire (Juniper)	Control	Change at 6 months	-0.18	95% Confidence Interval -0.42 to 0.07	score on a scale
N3-to-n6 PUFA Ratio (Granulocytes)	Omega-3 Fatty Acids	Baseline	0.06	95% Confidence Interval 0.03 to 0.08	no units (ratio)
N3-to-n6 PUFA Ratio (Granulocytes)	Control	Baseline	0.10	95% Confidence Interval 0.05 to 0.14	no units (ratio)
N3-to-n6 PUFA Ratio (Granulocytes)	Omega-3 Fatty Acids	3 months	0.19	95% Confidence Interval 0.09 to 0.28	no units (ratio)
N3-to-n6 PUFA Ratio (Granulocytes)	Control	3 months	0.08	95% Confidence Interval 0.03 to 0.14	no units (ratio)

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Omega-3 Fatty Acids	77
Overall Study	STARTED	Control	21
Overall Study	COMPLETED	Omega-3 Fatty Acids	68
Overall Study	COMPLETED	Control	17
Overall Study	NOT COMPLETED	Omega-3 Fatty Acids	9
Overall Study	NOT COMPLETED	Control	4

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headaches	Nervous system disorders	Omega-3 Fatty Acids	39	77
other	Headaches	Nervous system disorders	Control	8	21
other	Dry Mouth	Immune system disorders	Omega-3 Fatty Acids	14	77
other	Dry Mouth	Immune system disorders	Control	5	21
other	Nausea	Gastrointestinal disorders	Omega-3 Fatty Acids	21	77
other	Nausea	Gastrointestinal disorders	Control	4	21
other	Bloating	Gastrointestinal disorders	Omega-3 Fatty Acids	11	77
other	Bloating	Gastrointestinal disorders	Control	2	21
other	Diarrhea	Gastrointestinal disorders	Omega-3 Fatty Acids	11	77
other	Diarrhea	Gastrointestinal disorders	Control	5	21

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Omega-3 Fatty Acids	0	77
Total, all-cause mortality	Control	0	21
Total, other adverse events	Omega-3 Fatty Acids	58	77
Total, other adverse events	Control	15	21
Total, serious adverse events	Omega-3 Fatty Acids	3	77
Total, serious adverse events	Control	0	21

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30678465	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Omega-3 Fatty Acids vs Control: deaths from any cause	Trial comparisons
Omega-3 Fatty Acids vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants