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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Комбинированный продукт 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)

Первичные конечные точки

• ACPA levels [Срок оценки: At Day 0 and Day 84]

Вторичные конечные точки (1)

• Side-effect profile of COD [Срок оценки: At Day 0 and Day 84]

Критерии участия

Критерии включения

• Verified to be ACPA+ based on serum testing
• Age 18 to 65 years old
• Willing to provide contact information by email, telephone and mailing address
• Participant agrees to take the supplements every day for 84 days
• Female participants of child-bearing potential must be willing to ensure that they use 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
• If participant is currently taking curcumin, vitamin D and/or omega-3 supplements they must agree to a washout period of at least 1 month prior to the start of the 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.

Критерии исключения

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

• Current use of warfarin or similar anticoagulant medication (at the discretion of the P.I.)
• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
• Female of childbearing potential who is unwilling to use contraception during the trial
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
• Any 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 consumption of vitamin D, omega-3, curcumin supplements and/or curcumin containing product within the last 3 months and unwilling to stop consumption for at least a month prior to the start of the trial.
• Self-report of allergic reaction to fish
• 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. Once fully recovered they can participate.
• Participant has been recently vaccinated (past 4 weeks). Participant can continue in the trial 1-month after receiving the vaccination.
• Has vacation/s planned during the trial that may interfere with study monitoring and visit 2. The start of the trial can be adjusted to accommodate planned vacations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Канада · 2 центра

• Norway House Health Centre — Norway House
• Health Sciences Centre — Winnipeg

Идентификаторы

NCT: NCT06478290 · HS26482 (B2024:059)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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