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

(PASCOD3 Trial)

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

50 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Curcumin, Omega-3, and Vitamin D Supplements for healthy subjects?

Research suggests that vitamin D and omega-3 supplements may help reduce the risk of cancer and heart disease, as seen in the VITamin D and OmegA-3 TriaL (VITAL). However, more studies are needed to confirm these benefits in healthy people. ^{1 2 3 4 5}

Is it safe to take curcumin, omega-3, and vitamin D supplements?

Curcumin is generally considered safe by the US FDA, but it may interact with certain drugs. In animal studies, high doses of curcumin showed no harmful effects, though a small reduction in body weight was noted at the highest dose. Always consult with a healthcare provider before starting any new supplement. ^{6 7 8 9 10}

How does the treatment with Curcumin, Omega-3, and Vitamin D Supplements differ from other treatments?

This treatment is unique because it combines curcumin, omega-3 fatty acids, and vitamin D, which are being studied for their potential to prevent cancer and cardiovascular disease in healthy individuals. Unlike other treatments that may target existing conditions, this combination aims at primary prevention, meaning it is used to help prevent these diseases from developing in the first place. ^{1 2 5 11 12}

What is the purpose of this trial?

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.

Research Team

Liam O'Neil, MD, MHSc

Principal Investigator

University of Manitoba

Eligibility Criteria

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 surgery planned that will need general anesthesia during the trial.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: curcumin, omega-3, and vitamin D (COD) Experimental Treatment 1 Intervention

Acumin™Turmeric Complex/Dr. D's Ultra BioTurmeric: 500 mg/day (oral, 2 tablets taken by mouth), Vitamin D: 2500 IU/day (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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Impact of new vitamin D data on future studies and treatment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Vitamin D and the heart: why we need large-scale clinical trials. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The clinical efficacy of curcumin-containing nutraceuticals: An overview of systematic reviews. [2019]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A two generation reproductive toxicity study with curcumin, turmeric yellow, in Wistar rats. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Curcumin Supplementation and Human Disease: A Scoping Review of Clinical Trials. [2023]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Impact of Curcumin on Microsomal Enzyme Activities: Drug Interaction and Chemopreventive Studies. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL). [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Melanoma and vitamin D. [2023]