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Poly-unsaturated Fats for Improving Nasal Polyps and Asthma

NCT05613803 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-12-04

No results posted yet for this study

Summary

Asthma is a syndrome compromising many phenotypes including N-ERD (caused by increased 4-series leukotriene (LT) production). n-3 PUFA supplementation modulates 4-series LT and has anti-inflammatory effects. However, other than in a pilot study with dietary manipulation, the effects of N-ERD are unknown. The primary objective is to determine whether n-3 PUFA supplementation in people with N-ERD can improve asthma control using the asthma control questionnaire (ACQ-7). This is a placebo controlled randomised controlled parallel multicentre study with of 6g per day of PUFA for 6 months in people with N-ERD and poor asthma control

Conditions

Interventions

DRUG

Fish oil

6g of EPA and DHA in a 1.3:1 ratio as six Omacor capsules manufactured by Provona Biocare (Olso Norway), or generic equivalent, taken once daily, or in divided doses, with food.

OTHER

Placebo

Six capsules containing palm oil and soybean oil on an 8:2 ratio taken once daily, or in divided doses, with food.

Sponsors & Collaborators

  • University of East Anglia

    collaborator OTHER

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew Wilson · University of East Anglia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613803 on ClinicalTrials.gov