Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements in ACPA+ Individuals
NCT06478290 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-08-01
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
Interventions
- COMBINATION_PRODUCT
-
curcumin, omega-3, and vitamin D (COD)
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)
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
University of Manitoba
lead OTHER
Principal Investigators
-
Liam O'Neil, MD, MHSc · University of Manitoba
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2026-07-31
- Completion
- 2027-10-31
Countries
- Canada
Study Locations
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