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

NCT06478290 | Not Yet Recruiting

• 1 other identifier: HS26482 (B2024:059)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Healthy Participants

Keywords

Rheumatoid Arthritis; Curcumin; Omega-3; Vitamin D

Outcome Measures

Primary Outcomes (1)

• ACPA levels

  Anti-cyclic citrullinated peptide antibody (ACPA) levels will be determined with a CCP3.1 ELISA

  At Day 0 and Day 84

Secondary Outcomes (1)

• Side-effect profile of COD

  At Day 0 and Day 84

Other Outcomes (32)

• Waist circumference measures

  At Day 0 and Day 84

• Weight measures

  At Day 0 and Day 84

• Height measures

  At Day 0 and Day 84

Study Arms (1)

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)

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

Interventions

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)

Theracurmin, Vitamin D, and Omega-3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Norway House Health Centre

Norway House, Manitoba, R0B 1B0, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Curcumin; Docosahexaenoic Acids; Vitamin D

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Liam O'Neil, MD, MHSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liam O'Neil, MD, MHSc

CONTACT

+1 (204) 787-1851; liam.oneil@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study will have an open label pre-post design, so no randomization or blinding of treatment (COD) will occur.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 27, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CA (2)