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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| ACPA levels | Anti-cyclic citrullinated peptide antibody (ACPA) levels will be determined with a CCP3.1 ELISA | At Day 0 and Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Side-effect profile of COD | 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 | At Day 0 and Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference measures | Waist circumference in cm using a measuring tape | At Day 0 and Day 84 |
| Weight measures | Weight in kg using a scale |
Inclusion Criteria
Exclusion Criteria
The participant may not enter the trial if ANY of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liam O'Neil, MD, MHSc | Contact | +1 (204) 787-1851 | liam.oneil@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Liam O'Neil, MD, MHSc | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norway House Health Centre | Norway House | Manitoba | R0B 1B0 | Canada |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| D004281 | Docosahexaenoic Acids |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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This pilot study will have an open label pre-post design, so no randomization or blinding of treatment (COD) will occur.
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|
| At Day 0 and Day 84 |
| Height measures | Height in cm using a measuring tape | At Day 0 and Day 84 |
| Blood pressure measures | Systolic and diastolic Blood pressure will be measured in mmHg using blood pressure machine | At Day 0 and Day 84 |
| Tender and Swollen Joint Counts (TSJC) | 44 tender and swollen joint count will be performed by a rheumatologist | At Day 0 and Day 84 |
| SDAI | Simple Disease Activity Index (SDAI) assessment will be used to determine severity of RA using clinical and laboratory data | At Day 0 and Day 84 |
| CDAI | Clinical Disease Activity Index (CDAI) assessment will be used to determine severity of RA using clinical and laboratory data | At Day 0 and Day 84 |
| DAS28-CRP | The Disease Activity Score (DAS28)-CRP will be determined to assess RA disease activity, calculated once the C-reactive protein (CRP) result is available | At Day 0 and Day 84 |
| Hand grip strength | Hand grip strength will be measured using a Dynamometer in kg, taken in triplicate | At Day 0 and Day 84 |
| RAPID3 | Routine assessment of patient index data. Disease activity index calculated from a short and questionnaire | At Day 0 and Day 84 |
| White blood cells (WBC) | WBC measured in x10^9/L | At Day 0 and Day 84 |
| Hemoglobin | Hemoglobin measured in g/L | At Day 0 and Day 84 |
| Platelets | Platelets measured in x10^9/L | At Day 0 and Day 84 |
| Mean platelet volume (MVP) | MVP measured in fL | At Day 0 and Day 84 |
| BUN | The total blood urea concentration in mmol/L | At Day 0 and Day 84 |
| Magnesium | Magnesium measured in mmol/L | At Day 0 and Day 84 |
| Lipid profile | Total cholesterol, LDL, HDL, and Non-fasted triglycerides will be measured in mmol/L | At Day 0 and Day 84 |
| Albumin | Total blood albumin concentration in g/L | At Day 0 and Day 84 |
| Total and direct bilirubin | Total and direct bilirubin is measured in μmol/L | At Day 0 and Day 84 |
| Sodium | Total blood sodium concentration in mmol/L | At Day 0 and Day 84 |
| Potassium | Total blood potassium concentration in mmol/L | At Day 0 and Day 84 |
| Chloride | Total blood chloride concentration in mmol/L | At Day 0 and Day 84 |
| Bicarbonate HCO3 | Bicarbonate measured in mmol/L | At Day 0 and Day 84 |
| Creatinine | Total blood creatinine concentration in μmol/L | At Day 0 and Day 84 |
| AST | AST is measured in U/L | At Day 0 and Day 84 |
| ALT | ALT is measured in U/L | At Day 0 and Day 84 |
| ALP | ALP is measured in U/L | At Day 0 and Day 84 |
| GGT | GGT is measured in U/L | At Day 0 and Day 84 |
| Glucose | Total fasted blood glucose concentration in mmol/L | At Day 0 and Day 84 |
| Calcium | Total blood calcium concentration in mmol/L | At Day 0 and Day 84 |
| Phosphate (PO4) | Total blood phosphate concentration in mmol/L | At Day 0 and Day 84 |
| CRP | C-Reactive Protein (CRP) | At Day 0 and Day 84 |
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |