Rheumatoid ArthritisNCT00805116
Marine Oils and Arthritis
A study testing Whale blubber oil and Cod liver oil in people with Rheumatoid Arthritis, run by National Institute of Nutrition and Seafood Research, Norway.
Trial summary
NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk. Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Whale blubber oil and Cod liver oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis patients according to American College of Rheumatology criteria (with active disease and in remission). Intensity of joint pain last week (30 mm or more on 100 mm Visual analogue scale). Stable use of DMARDS and no corticosteroid injections last 4 weeks before study and during study.
Who cannot join
- Non-Norwegian speaking/reading or not understanding study design or non-compliance. Pregnant/lactating women. Bleeder disease, known HIV or hepatitis, medication with Marevan (blood thinner). Not willing or possible to stop taking regular omega-3 supplements during study.
About this study
Official title: Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis
NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk. Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome). Patients are assessed at inclusion and after study (4 months) during routine polyclinical visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g. morning stiffness, quality of life and functional level
Read the detailed description
Not relevant
- Conditions
- Rheumatoid Arthritis
- Being tested
- Whale blubber oil, Cod liver oil
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whale blubber oilDietary supplement
15 ml/day for 4 months, divided on dosage morning and evening, orally.
Cod liver oilDietary supplement
15 ml/day for 4 months, divided on dosage morning and evening, taken orally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Whale blubber oil Receives: Dietary Supplement: Whale blubber oil |
| 2 | Active comparator | Cod liver oil Receives: Dietary Supplement: Cod liver oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect a difference in 10 mm on visual analogue scale (intensity of joint pain last week) between the two treatment groups
Measured: At study end (4 months)
Secondary outcomes (3)
To detect a group difference in morning stiffness last week in minutes (720 min = 12 hours are limit for duration of morning stiffness recorded)
Measured: Study end (4 months)
To detect a difference between groups in quality of life using SF-36
Measured: Study end (4 months)
To see a group difference in functional level using MHAQ
Measured: Study end (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Recruitment to slow, most patients to well for treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nutrition and Seafood Research, Norway
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marian Kjellevold, National Institute of Nutrition and Seafood Research, Norway
- Investigators
- Livar Frøyland, Dr, Study director, NIFES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805116
- Sponsor's protocol ID
- 1523 Hvalolje (NIFES)
- Other IDs
- REK VEST 257.07, NSD 17989
- Status last verified
- May 2016
- First submitted
- 8 Dec 2008
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00805116
- Acronym / sponsor ID
- 1523 Hvalolje (NIFES)
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment to slow, most patients to well for treatment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institute of Nutrition and Seafood Research, NorwayOther government
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk. Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome). Patients are assessed at inclusion and after study (4 months) during routine polyclinical visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g. morning stiffness, quality of life and functional level
Detailed description
Not relevant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Whale blubber oilWhale blubber oil |
| 2 | Active comparator | Dietary Supplement: Cod liver oilCod liver oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid arthritis patients according to American College of Rheumatology criteria (with active disease and in remission). Intensity of joint pain last week (30 mm or more on 100 mm Visual analogue scale). Stable use of DMARDS and no corticosteroid injections last 4 weeks before study and during study.
Key exclusion criteria (1 listed)
- Non-Norwegian speaking/reading or not understanding study design or non-compliance. Pregnant/lactating women. Bleeder disease, known HIV or hepatitis, medication with Marevan (blood thinner). Not willing or possible to stop taking regular omega-3 supplements during study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whale blubber oil15 ml/day for 4 months, divided on dosage morning and evening, orally. | Dietary supplement | 1 |
| Cod liver oil15 ml/day for 4 months, divided on dosage morning and evening, taken orally | Dietary supplement | 2 |
Primary outcome
To detect a difference in 10 mm on visual analogue scale (intensity of joint pain last week) between the two treatment groups
Time frame: At study end (4 months)
3 secondary outcomes
To detect a group difference in morning stiffness last week in minutes (720 min = 12 hours are limit for duration of morning stiffness recorded)
Time frame: Study end (4 months)
To detect a difference between groups in quality of life using SF-36
Time frame: Study end (4 months)
To see a group difference in functional level using MHAQ
Time frame: Study end (4 months)
Results and safety
The study was stopped early (reason given: Recruitment to slow, most patients to well for treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livar Frøyland, Dr study director
NIFES
Questions about this trial
What is this clinical trial studying?
A study testing Whale blubber oil and Cod liver oil in people with Rheumatoid Arthritis, run by National Institute of Nutrition and Seafood Research, Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment to slow, most patients to well for treatment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect a difference in 10 mm on visual analogue scale (intensity of joint pain last week) between the two treatment groups (time frame: At study end (4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.