Healthy ParticipantsPASCOD3NCT06478290
Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements in ACPA+ Individuals
A study testing curcumin, omega-3, and vitamin D (COD) in people with Healthy Participants, run by University of Manitoba at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to determine if the level of Anti-cyclic citrullinated peptide antibody (ACPA) is altered after taking curcumin, omega-3, and vitamin D supplements (COD) for 3 months. It will also determine the safety and tolerability of COD in the study population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- curcumin, omega-3, and vitamin D (COD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Verified to be ACPA+ based on serum testing
- Age 18 to 65 years old
- Willing to provide contact information by email, telephone and mailing address
- Participant agrees to take the supplements every day for 84 days
- Female participants of child-bearing potential must be willing to ensure that they use contraception during the trial
- Participant has clinically acceptable laboratory results including routine hematology (CBC) and biochemistry (electrolytes, creatinine, ALT, ALP, GGT, AST, Glucose)
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- In the Investigator's opinion, is able and willing to comply with all trial requirements
- If participant is currently taking curcumin, vitamin D and/or omega-3 supplements they must agree to a washout period of at least 1 month prior to the start of the trial.
- Participant agrees to be followed longitudinally in the PRE-RA cohort study, following the completion of this trial.
- Participant is willing and able to give free informed consent and written consent in English, for participation in the trial.
Who cannot join
- The participant may not enter the trial if ANY of the following apply:
- Current use of warfarin or similar anticoagulant medication (at the discretion of the P.I.)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Female of childbearing potential who is unwilling to use contraception during the trial
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
- Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
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- Concurrent commitment to enroll in another clinical trial
- Regular consumption of vitamin D, omega-3, curcumin supplements and/or curcumin containing product within the last 3 months and unwilling to stop consumption for at least a month prior to the start of the trial.
- Self-report of allergic reaction to fish
- Participants who indicate that they will not consume the treatments on a daily basis
- Current consumption of > 14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
- Participants who report they have had viral or bacterial infection in the last 4 weeks (e.g. COVID-19, the flu, a cold, stomach flu, bladder infection, strep throat), and are not fully recovered. Once fully recovered they can participate.
- Participant has been recently vaccinated (past 4 weeks). Participant can continue in the trial 1-month after receiving the vaccination.
- Has vacation/s planned during the trial that may interfere with study monitoring and visit 2. The start of the trial can be adjusted to accommodate planned vacations.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Norway House Health Centre
Norway House, Manitoba, R0B 1B0
Liam O'Neil, MD, MHSc, +1 (204) 787-1851, liam.oneil@umanitoba.ca
Liam O'Neil, MD
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Liam O'Neil, MD, MHSc, +1 (204) 787-1851, liam.oneil@umanitoba.ca
Liam O'Neil, MD
About this study
Official title: Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements (PASCOD) in ACPA+ Individuals
The goal of this clinical trial is to determine if the level of Anti-cyclic citrullinated peptide antibody (ACPA) is altered after taking curcumin, omega-3, and vitamin D supplements (COD) for 3 months. It will also determine the safety and tolerability of COD in the study population. This trial aims to answer the following questions: Does COD consumption lower the level of ACPA in the study participants? What side effects will participants have after taking COD? This pilot study will have an open label pre-post design and study participants will know that they are using each of the three supplements. Participants will: Take the combination of supplements following an evening meal, for 84 consecutive days. Visit the clinic/study team twice during the study duration on days 0 and 84 for checkups and tests. Keep a diary of study treatment consumption.
Read the detailed description
Rheumatoid Arthritis (RA) is a prevalent autoimmune disease. Curcumin formulations are recognized for their potent anti-inflammatory effects, mainly targeting NF-kB signaling. Supplementation with Acumin™ has shown significant benefits for RA patients, including pain relief, reduced morning stiffness, and improved joint function, alongside decreases in inflammatory markers and autoantibody levels. In murine arthritis models, a bioavailable curcumin form, combined with a diet rich in vitamin D and omega-3, notably altered disease progression. Therefore, a pilot trial is set for anti-cyclic citrullinated peptide antibody+ (APCA+) individuals without RA. The primary objective of this study will determine if the level of ACPA is altered after taking curcumin, omega-3, and vitamin D (COD) for 3 months. The secondary objective is to determine the safety and tolerability of COD in the study population. Exploratory outcomes will include assessment of joint, symptoms, blood biochemistry and hematology. This study will enroll 50 ACPA+ individuals without RA, aiming for an equal distribution of male and female participants. Participants identified as ACPA+ from the RA Auto-antibody Detection study (RAAD) will undergo eligibility screening. The study will involve open-label administration of ACUMIN™ Turmeric Complex (500 mg), Omega-3 (900 mg), and Vitamin D3 (2500 IU) once daily for 84 consecutive days. Joint examinations will be conducted by a study physician, and blood specimens will be collected by certified phlebotomists at designated sites. Trained personnel will handle questionnaire surveys, anthropometrics, follow-ups, and coordinating visits. Data will be recorded on paper-based CRFs and entered into the secure REDCap database. The trial will take place at Health Sciences Centre (MS7) in Winnipeg for urban participants and in First Nation communities with established research agreements with the team (Norway House First Nation).
- Conditions
- Healthy Participants
- Being tested
- curcumin, omega-3, and vitamin D (COD)
- Keywords
- Rheumatoid Arthritis, Curcumin, Omega-3, Vitamin D
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin, omega-3, and vitamin D (COD)Combination product
Combination of curcumin, omega-3, and vitamin D supplements (COD). Theracurmin Double Strength/Natural Factors Canada 180 mg/day (oral, 3 tablets of 60 mg taken by mouth) Vitamin D: 2000 IU/day LipoMicel/Natural Factors Canada (oral, 1 tablet taken by mouth) Omega-3: 900 mg day (oral, 1 tablet taken by mouth)
| Study group | Role | What they receive |
|---|---|---|
| Theracurmin, Vitamin D, and Omega-3 | Experimental | Theracurmin Double Strength: 180 mg/day (oral, 3 tablets of 60 mg taken by mouth) Vitamin D: 2000 IU/day LipoMicel (oral, 1 tablet taken by mouth) Omega-3: 900 mg day (oral, 1 tablet taken by mouth) Receives: Combination Product: curcumin, omega-3, and vitamin D (COD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACPA levels
Anti-cyclic citrullinated peptide antibody (ACPA) levels will be determined with a CCP3.1 ELISA
Measured: At Day 0 and Day 84
Secondary outcomes (1)
Side-effect profile of COD
Side-effect profile and prevalence of side-effects of Theracurmin Double Strength, Omega-3, and Vitamin D supplementation will be determined through monitoring the blood results for biochemical and haematology analysis
Measured: At Day 0 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Oct 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot study will have an open label pre-post design, so no randomization or blinding of treatment (COD) will occur.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Liam O'Neil, MD, MHSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478290
- Sponsor's protocol ID
- HS26482 (B2024:059)
- Acronym
- PASCOD3
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements (PASCOD) in ACPA+ Individuals
- ClinicalTrials.gov ID
- NCT06478290
- Acronym / sponsor ID
- PASCOD3 / HS26482 (B2024:059)
- Conditions
- Healthy Participants
- Keywords
- Rheumatoid Arthritis, Curcumin, Omega-3, Vitamin D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- 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.
The goal of this clinical trial is to determine if the level of Anti-cyclic citrullinated peptide antibody (ACPA) is altered after taking curcumin, omega-3, and vitamin D supplements (COD) for 3 months. It will also determine the safety and tolerability of COD in the study population. This trial aims to answer the following questions: Does COD consumption lower the level of ACPA in the study participants? What side effects will participants have after taking COD? This pilot study will have an open label pre-post design and study participants will know that they are using each of the three supplements. Participants will: Take the combination of supplements following an evening meal, for 84 consecutive days. Visit the clinic/study team twice during the study duration on days 0 and 84 for checkups and tests. Keep a diary of study treatment consumption.
Detailed description
Rheumatoid Arthritis (RA) is a prevalent autoimmune disease. Curcumin formulations are recognized for their potent anti-inflammatory effects, mainly targeting NF-kB signaling. Supplementation with Acumin™ has shown significant benefits for RA patients, including pain relief, reduced morning stiffness, and improved joint function, alongside decreases in inflammatory markers and autoantibody levels. In murine arthritis models, a bioavailable curcumin form, combined with a diet rich in vitamin D and omega-3, notably altered disease progression. Therefore, a pilot trial is set for anti-cyclic citrullinated peptide antibody+ (APCA+) individuals without RA. The primary objective of this study will determine if the level of ACPA is altered after taking curcumin, omega-3, and vitamin D (COD) for 3 months. The secondary objective is to determine the safety and tolerability of COD in the study population. Exploratory outcomes will include assessment of joint, symptoms, blood biochemistry and hematology. This study will enroll 50 ACPA+ individuals without RA, aiming for an equal distribution of male and female participants. Participants identified as ACPA+ from the RA Auto-antibody Detection study (RAAD) will undergo eligibility screening. The study will involve open-label administration of ACUMIN™ Turmeric Complex (500 mg), Omega-3 (900 mg), and Vitamin D3 (2500 IU) once daily for 84 consecutive days. Joint examinations will be conducted by a study physician, and blood specimens will be collected by certified phlebotomists at designated sites. Trained personnel will handle questionnaire surveys, anthropometrics, follow-ups, and coordinating visits. Data will be recorded on paper-based CRFs and entered into the secure REDCap database. The trial will take place at Health Sciences Centre (MS7) in Winnipeg for urban participants and in First Nation communities with established research agreements with the team (Norway House First Nation).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study will have an open label pre-post design, so no randomization or blinding of treatment (COD) will occur.
| Arm | Type | Receives |
|---|---|---|
| Theracurmin, Vitamin D, and Omega-3 | Experimental | Combination Product: curcumin, omega-3, and vitamin D (COD)Theracurmin Double Strength: 180 mg/day (oral, 3 tablets of 60 mg taken by mouth) Vitamin D: 2000 IU/day LipoMicel (oral, 1 tablet taken by mouth) Omega-3: 900 mg day (oral, 1 tablet taken by mouth) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Verified to be ACPA+ based on serum testing
- Age 18 to 65 years old
- Willing to provide contact information by email, telephone and mailing address
- Participant agrees to take the supplements every day for 84 days
- Female participants of child-bearing potential must be willing to ensure that they use contraception during the trial
Key exclusion criteria (14 listed)
- Current use of warfarin or similar anticoagulant medication (at the discretion of the P.I.)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Female of childbearing potential who is unwilling to use contraception during the trial
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
- Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
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 |
|---|---|---|
| curcumin, omega-3, and vitamin D (COD)Combination of curcumin, omega-3, and vitamin D supplements (COD). Theracurmin Double Strength/Natural Factors Canada 180 mg/day (oral, 3 tablets of 60 mg taken by mouth) Vitamin D: 2000 IU/day LipoMicel/Natural Factors Canada (oral, 1 tablet taken by mouth) Omega-3: 900 mg day (oral, 1 tablet taken by mouth) | Combination product | Theracurmin, Vitamin D, and Omega-3 |
Primary outcome
ACPA levels
Time frame: At Day 0 and Day 84
Anti-cyclic citrullinated peptide antibody (ACPA) levels will be determined with a CCP3.1 ELISA
1 secondary outcome
Side-effect profile of COD
Time frame: At Day 0 and Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Liam O'Neil, MD, MHSc principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcumin, omega-3, and vitamin D (COD) in people with Healthy Participants, run by University of Manitoba at 2 sites in Canada.
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 10 inclusion and 14 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: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liam O'Neil, MD, MHSc (+1 (204) 787-1851, liam.oneil@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACPA levels (time frame: At Day 0 and Day 84). 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 1 Aug 2025.