Curcumin, Omega-3, and Vitamin D Supplements for Healthy Subjects

(PASCOD3 Trial)

Not yet recruiting at 1 trial location

Overseen By Liam O'Neil, MD, MHSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Warfarin

Disqualifiers: Autoimmune, Cardiovascular, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mix of curcumin, omega-3, and vitamin D supplements can lower levels of ACPA, an antibody linked to certain autoimmune conditions. Researchers aim to determine if these supplements are safe and well-tolerated. Participants will take the supplements daily for three months and record their experiences. Individuals with high ACPA levels who are willing to stop current supplement use for a month beforehand may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of these supplements for autoimmune conditions.

Will I have to stop taking my current medications?

If you are currently taking vitamin D and/or omega-3 supplements, you will need to stop taking them before starting this trial. The protocol does not specify about other medications, so it's best to discuss your specific situation with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that curcumin, omega-3, and vitamin D are generally safe for people. One study on curcumin found no harmful effects, suggesting regular use is safe. Omega-3 and vitamin D, common in supplements, are usually well-tolerated. Most people taking these supplements do not experience serious side effects, though mild issues like an upset stomach or nausea can occur. Overall, current evidence considers using these supplements together safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine natural supplements like Theracurmin, a highly absorbable form of curcumin, with vitamin D and omega-3 fatty acids. Unlike standard supplements, Theracurmin has enhanced bioavailability, meaning the body can absorb it more effectively, potentially boosting its anti-inflammatory benefits. Moreover, these supplements collectively target inflammation and support overall health, which is different from conventional approaches that might rely on synthetic drugs. This combination may offer a holistic alternative to maintaining health, emphasizing natural ingredients and improved absorption.

What evidence suggests that curcumin, omega-3, and vitamin D supplements might be effective for altering ACPA levels?

Research has shown that taking curcumin, vitamin D, and omega-3 supplements together may lower the risk of developing diabetes in pre-diabetic individuals. One study found that a type of curcumin, when combined with vitamin D, effectively eases the onset of certain health issues. Curcumin and omega-3 fatty acids have also been studied for their potential to boost brain function by improving blood flow in the brain. While these studies suggest possible benefits, this trial specifically examines how Theracurmin, Vitamin D, and Omega-3 affect a certain antibody level, which remains unproven. ^{1 3 6 7 8}

Who Is on the Research Team?

Liam O'Neil, MD, MHSc

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for healthy individuals who have a specific antibody called ACPA in their blood. Participants will be taking a combination of supplements—curcumin, omega-3, and vitamin D—for three months to see if it affects the levels of ACPA.

Inclusion Criteria

I am willing to stop taking my vitamin D and omega-3 supplements for this trial.

I am willing to use effective birth control during the trial.

Participant has clinically acceptable laboratory results including routine hematology (CBC) and biochemistry (electrolytes, creatinine, ALT, ALP, GGT, AST, Glucose)

Exclusion Criteria

I have lost or gained more than 3.5 kg in the last 3 months without a known reason.

Current consumption of > 14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)

I have surgery planned that will need general anesthesia during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a combination of curcumin, omega-3, and vitamin D supplements for 84 consecutive days

12 weeks

2 visits (in-person) on Day 0 and Day 84

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin, Omega-3, and Vitamin D Supplements

Trial Overview The study tests whether consuming curcumin, omega-3, and vitamin D (COD) can lower Anti-cyclic citrullinated peptide antibody (ACPA) levels. It's an open-label pre-post design where participants know they're taking the supplements and must follow up with the clinic on days 0 and 84.

How Is the Trial Designed?

Group I: Theracurmin, Vitamin D, and Omega-3 Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Quercetin-decorated liposomes containing curcumin showed improved effectiveness in increasing the lifespan and body weight of mice with Dalton's ascites lymphoma compared to liposomes without quercetin, indicating enhanced therapeutic potential.

The study demonstrated that these liposomes, with a particle size of approximately 261.8 nm, not only improved the cytotoxicity against cancer cells (HT-29 and HCT-15) but also addressed curcumin's limitations like poor solubility and short biological half-life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. Ravichandiran, V., Masilamani, K., Senthilnathan, B., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7836561/

A bioavailable form of curcumin, in combination with ... In the current study, we showed that bioavailable CUR is maximally effective in ameliorating the onset of CIA when combined with vitamin D and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5126844/

Curcumin and long-chain Omega-3 polyunsaturated fatty ... In the current trial we propose to evaluate the effects of curcumin and/or long-chain omega-3 polyunsaturated fatty acids on improving ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622024087

Evaluation of Cognitive Performance following Fish-Oil and ... The aim was to test the hypothesis that supplementation with fish oil and curcumin can enhance cognitive performance by improving cerebral circulatory function.

4. nature.com nature.com/articles/s41598-025-16129-8

A systematic review and dose response meta analysis of ... Fish oil supplementation does not affect cognitive outcomes in cardiac surgery patients in the Omega-3 fatty acids for prevention of Post ...

5. nutraingredients.com nutraingredients.com/Article/2023/03/08/curcumin-vitamin-d-fish-oil-could-prevent-worsening-of-pre-diabetics-study/

Curcumin, vitamin D, fish oil shown to prevent progression ... The supplementation of curcumin, vitamin D, and fish oil together has shown to reduce the progression to diabetes in pre-diabetic ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2214750021001141

Safety assessment of a highly bioavailable curcumin ... In summary, no adverse effects were observed under the conditions of the study. CGM can be considered as a safe curcumin supplement for regular consumption and ...

7. jn.nutrition.org jn.nutrition.org/article/S0022-3166(22)02408-7/fulltext

Evaluation of Cognitive Performance following Fish-Oil and ... The aim was to test the hypothesis that supplementation with fish oil and curcumin can enhance cognitive performance by improving cerebral circulatory function.

8. drhoffman.com drhoffman.com/article/nutrients-in-the-news-fish-oil-magnesium-vitamin-d-and-curcumin/

Nutrients in the News: Fish oil, magnesium, vitamin D and ... Curcumin, already recognized for its antiviral potential, thus joins the suite of nutrients like garlic, fish oil, magnesium and resveratrol that may confer ...