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

Not Applicable

Not yet recruiting

• Conditions: Healthy Participants

• Registration Number: NCT06478290
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Rheumatoid Arthritis (RA) is a prevalent autoimmune disease. Curcumin formulations are recognized for their potent anti-inflammatory effects, mainly targeting NF-kB signaling. Supplementation with Acumin™ has shown significant benefits for RA patients, including pain relief, reduced morning stiffness, and improved joint function, alongside decreases in inflammatory markers and autoantibody levels. In murine arthritis models, a bioavailable curcumin form, combined with a diet rich in vitamin D and omega-3, notably altered disease progression. Therefore, a pilot trial is set for anti-cyclic citrullinated peptide antibody+ (APCA+) individuals without RA. The primary objective of this study will determine if the level of ACPA is altered after taking curcumin, omega-3, and vitamin D (COD) for 3 months. The secondary objective is to determine the safety and tolerability of COD in the study population. Exploratory outcomes will include assessment of joint, symptoms, blood biochemistry and hematology. This study will enroll 50 ACPA+ individuals without RA, aiming for an equal distribution of male and female participants. Participants identified as ACPA+ from the RA Auto-antibody Detection study (RAAD) will undergo eligibility screening. The study will involve open-label administration of ACUMIN™ Turmeric Complex (500 mg), Omega-3 (900 mg), and Vitamin D3 (2500 IU) once daily for 84 consecutive days. Joint examinations will be conducted by a study physician, and blood specimens will be collected by certified phlebotomists at designated sites. Trained personnel will handle questionnaire surveys, anthropometrics, follow-ups, and coordinating visits. Data will be recorded on paper-based CRFs and entered into the secure REDCap database. The trial will take place at Health Sciences Centre (MS7) in Winnipeg for urban participants and in First Nation communities with established research agreements with the team (Norway House First Nation).

Study Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-08-01
• Study Start: 2025-10-01
• Primary Completion: 2026-07
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ACPA levels	At Day 0 and Day 84	Anti-cyclic citrullinated peptide antibody (ACPA) levels will be determined with a CCP3.1 ELISA

Secondary Outcome Measures

Name	Time	Method
Side-effect profile of COD	At Day 0 and Day 84	Side-effect profile and prevalence of side-effects of Theracurmin Double Strength, Omega-3, and Vitamin D supplementation will be determined through monitoring the blood results for biochemical and haematology analysis

Trial Locations

Locations (2)

Norway House Health Centre; 🇨🇦 Norway House, Manitoba, Canada

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada