Clinical trial NCT06478290: Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements in ACPA+ Individuals
Official title: Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements (PASCOD) in ACPA+ Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Participants
Keywords: Rheumatoid Arthritis
Curcumin
Omega-3
Vitamin D
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study will have an open label pre-post design, so no randomization or blinding of treatment (COD) will occur.
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

* Verified to be ACPA+ based on serum testing without RA
* Age between 18 and 65 years old
* Female participants of child-bearing potential must be willing to ensure that they use effective 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
* Participants currently taking vitamin D and/or omega-3 supplements are willing to stop taking their own supplements prior to the start of this 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.

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

* Any history of clinically important and poorly controlled autoimmune disorders, endocrine disorders, cardiovascular disease, pulmonary, biliary or GI disorders, or any history of cancer requiring chemotherapy or radiation within the last 1 year
* Current use of warfarin or similar anticoagulant medication (at the discretion of the P.I.)
* Stomach ulcers (e.g., active peptic ulcer disease within the last 6 weeks) or poorly controlled gastric esophageal reflux disease (GERD)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
* Female of childbearing potential who is unwilling to ensure effective contraception during the trial
* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
* Any other 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 daily consumption of a Curcumin containing product within the last three months
* Self-report of allergic reaction to fish
* Self-reported body weight change of greater than 3.5 kg within the past 3 months, unexplained by medical history
* 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.

Primary outcomes:
measure: ACPA levels
timeFrame: At Day 0 and Day 84
Secondary outcomes:
measure: Side-effect profile of COD
timeFrame: At Day 0 and Day 84
Other outcomes:
measure: Waist circumference measures
timeFrame: At Day 0 and Day 84
measure: Weight measures
timeFrame: At Day 0 and Day 84
measure: Height measures
timeFrame: At Day 0 and Day 84
measure: Blood pressure measures
timeFrame: At Day 0 and Day 84
measure: Tender and Swollen Joint Counts (TSJC)
timeFrame: At Day 0 and Day 84
measure: SDAI
timeFrame: At Day 0 and Day 84
measure: CDAI
timeFrame: At Day 0 and Day 84
measure: DAS28-CRP
timeFrame: At Day 0 and Day 84
measure: Hand grip strength
timeFrame: At Day 0 and Day 84
measure: RAPID3
timeFrame: At Day 0 and Day 84
measure: White blood cells (WBC)
timeFrame: At Day 0 and Day 84
measure: Hemoglobin
timeFrame: At Day 0 and Day 84
measure: Platelets
timeFrame: At Day 0 and Day 84
measure: Mean platelet volume (MVP)
timeFrame: At Day 0 and Day 84
measure: BUN
timeFrame: At Day 0 and Day 84
measure: Magnesium
timeFrame: At Day 0 and Day 84
measure: Lipid profile
timeFrame: At Day 0 and Day 84
measure: Albumin
timeFrame: At Day 0 and Day 84
measure: Total and direct bilirubin
timeFrame: At Day 0 and Day 84
measure: Sodium
timeFrame: At Day 0 and Day 84
measure: Potassium
timeFrame: At Day 0 and Day 84
measure: Chloride
timeFrame: At Day 0 and Day 84
measure: Bicarbonate HCO3
timeFrame: At Day 0 and Day 84
measure: Creatinine
timeFrame: At Day 0 and Day 84
measure: AST
timeFrame: At Day 0 and Day 84
measure: ALT
timeFrame: At Day 0 and Day 84
measure: ALP
timeFrame: At Day 0 and Day 84
measure: GGT
timeFrame: At Day 0 and Day 84
measure: Glucose
timeFrame: At Day 0 and Day 84
measure: Calcium
timeFrame: At Day 0 and Day 84
measure: Phosphate (PO4)
timeFrame: At Day 0 and Day 84
measure: CRP
timeFrame: At Day 0 and Day 84
Locations:
city: Norway House
country: Canada
facility: Norway House Health Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Liam O'Neil, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References: