Rheumatoid ArthritisNCT01618019
N-3 PUFA and Rheumatoid Arthritis in Korea
A study testing Omega-3 fatty acid in people with Rheumatoid Arthritis, run by Hanyang University at 1 site in South Korea.
Trial summary
The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid (PUFA) can be beneficial for the patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Omega-3 fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline and receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.
Who cannot join
- Patients were excluded if they were pregnant, lactating, under the age of 18 or over age 80, taking supplements containing n-3 PUFA, white blood cell (WBC) ≤ 3.5 × 109/L, hemoglobin (Hb) ≤ 8.5 g/dL, platelet ≤ 100 × 109/L, creatinine ≥ 2.0 mg/dL, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times upper limit of normal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis
The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid (PUFA) can be beneficial for the patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Omega-3 fatty acid, Placebo
- Keywords
- n-3 PUFA, rheumatoid arthritis, inflammation, eicosanoids, bone turnover markers
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDietary supplement
Also called Ropufa 75 n-3, DSM Nutritional products, Switzerland
5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
PlaceboDietary supplement
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
| Study group | Role | What they receive |
|---|---|---|
| N-3 PUFA | Experimental | 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid Receives: Dietary Supplement: Omega-3 fatty acid |
| Placebo | Placebo comparator | 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of NSAID
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
Measured: 16 week
Secondary outcomes (7)
Duration of Morning Stiffness
Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.
Measured: 16 week
Physician's Global Assessment
Physician's global assessment is ranged from 0 to 10 by the assessing physician.
(0= no pain; 10= very severe pain)
Measured: 16 week
Patient's Global Assessment
Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)
Measured: 16 week
Pain Scale
Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)
Measured: 16 week
Osteocalcin Concentration
serum Osteocalcin concentration as nmol/L
Measured: 16 week
BSAP Concentration
serum bone specific alkaline phosphatase concentration as U/L
Measured: 16 week
CTX Concentration
serum C-terminal telopeptide of type 1 collagen concentration as nmol/L
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsoon Park, Hanyang University
- Investigators
- Yongsoon Park, PhD, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618019
- Sponsor's protocol ID
- HYUH-C55
- Other IDs
- KRF-2010-000-8656
- Status last verified
- Aug 2012
- First submitted
- 8 Jun 2012
- Last updated
- 2 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Park Y, Lee A, Shim SC, Lee JH, Choe JY, Ahn H, Choi CB, Sung YK, Bae SC. Effect of n-3 polyunsaturated fatty acid supplementation in patients with rheumatoid arthritis: a 16-week randomized, double-blind, placebo-controlled, parallel-design multicenter study in Korea. J Nutr Biochem. 2013 Jul;24(7):1367-72. doi: 10.1016/j.jnutbio.2012.11.004. Epub 2013 Jan 17.
PubMed 23333088
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01618019
- Acronym / sponsor ID
- HYUH-C55
- Conditions
- Rheumatoid Arthritis
- Keywords
- n-3 PUFA, rheumatoid arthritis, inflammation, eicosanoids, bone turnover markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Posted 2 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid (PUFA) can be beneficial for the patients with rheumatoid arthritis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-3 PUFA | Experimental | Dietary Supplement: Omega-3 fatty acid5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid |
| Placebo | Placebo comparator | Dietary Supplement: Placebo5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline and receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.
Key exclusion criteria (1 listed)
- Patients were excluded if they were pregnant, lactating, under the age of 18 or over age 80, taking supplements containing n-3 PUFA, white blood cell (WBC) ≤ 3.5 × 109/L, hemoglobin (Hb) ≤ 8.5 g/dL, platelet ≤ 100 × 109/L, creatinine ≥ 2.0 mg/dL, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times upper limit of normal.
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 |
|---|---|---|
| Omega-3 fatty acidAlso: Ropufa 75 n-3, DSM Nutritional products, Switzerland5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid | Dietary supplement | N-3 PUFA |
| Placebo5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) | Dietary supplement | Placebo |
Primary outcome
Dose of NSAID
Time frame: 16 week
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
7 secondary outcomes
Duration of Morning Stiffness
Time frame: 16 week
Physician's Global Assessment
Time frame: 16 week
Patient's Global Assessment
Time frame: 16 week
Pain Scale
Time frame: 16 week
Osteocalcin Concentration
Time frame: 16 week
BSAP Concentration
Time frame: 16 week
CTX Concentration
Time frame: 16 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23333088Park Y, Lee A, Shim SC, Lee JH, Choe JY, Ahn H, Choi CB, Sung YK, Bae SC. Effect of n-3 polyunsaturated fatty acid supplementation in patients with rheumatoid arthritis: a 16-week randomized, double-blind, placebo-controlled, parallel-design multicenter study in Korea. J Nutr Biochem. 2013 Jul;24(7):1367-72. doi: 10.1016/j.jnutbio.2012.11.004. Epub 2013 Jan 17.
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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.
Yongsoon Park, PhD principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid in people with Rheumatoid Arthritis, run by Hanyang University at 1 site in South Korea.
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: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose of NSAID (time frame: 16 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618019, which also lists 1 linked publication.
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 2 Oct 2012.