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Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements in ACPA+ Individuals

Not Yet RecruitingNA

Sponsor: University of Manitoba

Conditions: Healthy Participants

Interventions: curcumin, omega-3, and vitamin D (COD)

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* 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)
* 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.

Exclusion Criteria

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.
* 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.

Locations (2)

Norway House, Manitoba, Canada
Winnipeg, Manitoba, Canada