NCT05137132Completed
Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics
A Randomized Controlled, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of CARDIO® in Adult Asthmatics
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
Research has over decades showed that marine food carries nutritional characteristics that promote human health. As seen in epidemiological studies and based on in vitro and in vivo studies, it is hypothesized that unrefined salmon oil as dietary supplement have anti-inflammatory effect. However, there is sufficient preliminary data to indicate bioactive compounds effect for clinical use, and further clinical trials investigating effect are needed. This trial will investigate the potential anti-inflammatory effect in adults diagnosed with asthma.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 29 Oct 2021
- Start date
- 1 Apr 2022
- Primary completion date
- 9 Dec 2024
- Lead sponsor
- Hofseth Biocare ASA
- Diseases
- Asthma
- NCT number
- NCT05137132
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 1 Apr 2022 to the primary completion date, 9 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with oral corticosteroid \<1 month prior to baseline visit
- Treatment with any biological medication, \<6 months prior to baseline visit
- Oral/intravenous antibiotics \< 3 months prior to baseline visit
- Consumption of fish oil (liquid, capsule, powder) as an oral supplement \< 1-month prior baseline visit
Other illness
- Known fish or shellfish allergy
- Inflammatory bowel disease (Chron, ulcerative colitis (UC), microscopic colitis), celiac disease, or any chronic disease that possibly affects intestinal absorption and morbidity
- In case of severe cognitive impairment where the participants are not able to fulfill the study
Other
- Pregnancy and breast feeding
- Participant in a confounding study
- Not willing to participate
- Any reason why, in the opinion of the investigator, the participant cannot participate.
Who the study is looking for
- Asthma Global Initiative for Asthma (GINA) treatment grade 2-4 (only standard care of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), no additional treatment except as-needed short--acting beta2-agonist (SABA)
- ACQ-5 score ≥0.75
- Diagnosed with asthma by medical doctor (general practitioner or pulmonary spesialist)
- Eosinophils ≥ 150 µL
- Speaks fluent Norwegian.
- For female in fertile age, use of contraception or other indication for non-pregnancy.
- Signed informed consent and expected cooperation of the participants for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hofseth Biocare ASA Coordinator of this site? Confirm its status | Ålesund | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.