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Nutritional Supplements

Curcumin, Omega-3, and Vitamin D Supplements for Healthy Subjects (PASCOD3 Trial)

N/A

Waitlist Available

Led By Liam O'Neil, MD, MHSc

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Verified to be ACPA+ based on serum testing without RA

Age between 18 and 65 years old

Must not have

Scheduled elective surgery or other procedures requiring general anaesthesia during the trial

Self-reported body weight change of greater than 3.5 kg within the past 3 months, unexplained by medical history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 0 and day 84

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate if taking curcumin, omega-3, and vitamin D supplements for 3 months can change the level of a specific antibody in the body. Participants will take the supplements daily

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from COD may include digestive discomfort such as nausea or diarrhea, allergic reactions, or changes in mood or sleep due to omega-3 or vitamin D. The full range of side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood test shows ACPA positive but I don't have rheumatoid arthritis.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I will not take the treatments every day.

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I haven't had serious autoimmune, heart, lung, liver, or GI issues, or cancer treatments in the last year.

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I am not pregnant, breastfeeding, or planning to become pregnant during the trial.

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I am a woman who can have children and do not agree to use birth control during the trial.

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I have not had a stomach ulcer or severe acid reflux in the last 6 weeks.

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I have had a viral or bacterial infection in the last 4 weeks and am not fully recovered.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 0 and day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 0 and day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 0 and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ACPA levels

Secondary study objectives

Side-effect profile of COD

Other study objectives

ALP

ALT

AST

+29 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: curcumin, omega-3, and vitamin D (COD)Experimental Treatment1 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)

0 / 10Eligibility criteria met