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

Study Overview
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Brief Summary
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Curcumin, Omega-3 and Vitamin-D (COD) are commonly used dietary supplements, which are licensed natural health products in Canada. The investigators are interested to see what effects (good or bad) these supplements taken in combination, might have on a person and the potential impact of these supplements, in combination, on inflammation and the immune system, in the body. This is because the investigators study Rheumatoid Arthritis (RA), an autoimmune disease that affects the joints of the body, causing joint pain and swelling. The investigators want to first evaluate the tolerability and potential negative effects of these three supplements in combination, also known as side-effects in healthy persons. This pilot study will also help us determine the length of time research participants need for their research visits for future clinical trials. The investigators also want to explore the utility and validity of two different 24-hour food recall methods (ASA24-Canada-2018 and Keenoa food diary) and the dietary inflammatory index (DII) using both recall methods. The DII is a score calculated from dietary data, to establish the inflammatory potential of an individual's diet. This research pilot study aims to enroll 50 persons. The investigators want to identify common side effects of the supplements when all three are taken together, as well as any other potential side-effects that might occur that are not common. Based on the scientific research, persons who have taken these supplements individually (e.g., Vitamin D alone or Omega-3 alone), show that serious side effects are unlikely and if they do occur are mild. Pure curcumin, like that being administered in this study, containing no fillers, has not shown to have adverse effects and is well tolerated. However, no scientific studies have been done using all three of these nutritional supplements together, in humans.

Official Title
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Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements (PASCOD) in Healthy Human Volunteers

Conditions
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Healthy Participants

Intervention / Treatment
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* Dietary Supplement: Curcumin, Omega-3 and Vitamin-D (COD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give free informed consent and written consent in English, for participation in the trial Participant will provide contact information that includes telephone, email address and mailing address Age between 18 and 49 years old BMI range between 18.5 - 34.9 (kg/m2) 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 Participant is an employee or student at the Health Sciences Centre or Bannatyne Campus, by self-report 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 has received two-doses of a COVID-19 vaccine, with the second dose occurring no less than 4 weeks before Visit 1 Exclusion Criteria: 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 anesthesia 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 Recent history (within 12 months of screening) or 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 Participants who have been vaccinated in the last 4 weeks and in the opinion of the Investigator may influence the result of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin, Omega-3 and Vitamin-D (COD)<br> | Dietary Supplement: Curcumin, Omega-3 and Vitamin-D (COD)<br>* Acumin™ Turmeric Complex (Dr. D's Ultra BioTurmeric) 500 mg daily (NPN 80087842) Omega-3 supplements (combination of DHA and EPA) 900 mg daily (NPN 80019234) Vitamin D3 supplements 2500 IU daily (NPN 80108995)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Side Effects due to Supplements | Participants will fill out a weekly monitoring survey to report side effects and health issues they may have had over the past week while taking the COD supplements. Participants will fill out a short survey weekly using a 0-3 scale of severity for a variety of gastrointestinal and health symptoms to analyze total side effects over the trial. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supplementation adherence | Medication adherence (>75% pills consumed) Non-adherence (<75% of the capsules consumed) Medication packs will be returned on Day 28 (+/- 2 days) of the trial. Remaining capsules will be counted and deemed to have been missed. | Day 28 |