Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements in ACPA+ Individuals
NCT Number: NCT06478290
Acronym: PASCOD3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Participants
Interventions: COMBINATION_PRODUCT: curcumin, omega-3, and vitamin D (COD)
Sponsor: University of Manitoba
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2026-07
Locations: Norway House Health Centre, Norway House, Manitoba, R0B 1B0, Canada|Health Sciences Centre, Winnipeg, Manitoba, R3A 1R9, Canada

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.

Primary Outcome Measures: ACPA levels, Anti-cyclic citrullinated peptide antibody (ACPA) levels will be determined with a CCP3.1 ELISA, At Day 0 and Day 84
Secondary Outcome Measures: Side-effect profile of COD, Side-effect profile and prevalence of side-effects of Acumin™ Turmeric complex, 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
Other Outcome Measures: 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, 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