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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Dietary supplement: Curcumin, Omega-3 and Vitamin-D (COD)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin McFadyen, MPH; Phone Number: 204-787-8803; Email: caitlin.mcfadyen@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin, Omega-3 and Vitamin-D (COD)	Dietary supplement: Curcumin, Omega-3 and Vitamin-D (COD); 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine transaminase (ALT)	ALT is measured in U/L	Baseline, Day 28
Aspartate Aminotransferase (AST)	AST is measured in U/L	Baseline, Day 28
Alkaline Phosphatase (ALK)	AST is measured in U/L	Baseline, Day 28
Total Bilirubin	Total blood bilirubin is measured in μmol/L	Baseline, Day 28
Direct Bilirubin	Direct bilirubin is measured in μmol/L	Baseline, Day 28
Urea	The total blood urea concentration in mmol/L	Baseline, Day 28
Glucose	Total fasted blood glucose concentration in mmol/L	Baseline, Day 28
Total Cholesterol	Total cholesterol measured in mmol/L	Baseline, Day 28
Low-density lipoprotein (LDL)	LDL measured in mmol/L	Baseline, Day 28
High-density lipoprotein (HDL)	HDL measured in mmol/L	Baseline, Day 28
Triglycerides	Non-fasted triglycerides measured in mmol/L	Baseline, Day 28
Sodium	Total blood sodium concentration in mmol/L	Baseline, Day 28
Potassium	Total blood potassium concentration in mmol/L	Baseline, Day 28
Chloride	Total blood chloride concentration in mmol/L	Baseline, Day 28
Calcium	Total blood calcium concentration in mmol/L	Baseline, Day 28
Bicarbonate	Bicarbonate measured in mmol/L	Baseline, Day 28
Magnesium	Magnesium measured in mmol/L	Baseline, Day 28
Albumin	Total blood albumin concentration in g/L	Baseline, Day 28
Phosphate	Total blood phosphate concentration in mmol/L	Baseline, Day 28
Creatinine	Total blood creatinine concentration in μmol/L	Baseline, Day 28
C-Reactive Protein (CRP)	CRP measured in mg/L	Baseline, Day 28
White blood cells (WBC)	WBC measured in x10^9/L	Baseline, Day 28
Hemoglobin	Hemoglobin measured in g/L	Baseline, Day 28
Platelets	Platelets measured in x10^9/L	Baseline, Day 28
Mean platelet volume (MVP)	MVP measured in fL	Baseline, Day 28
Body weight	Body weight will be measured in kg	Baseline, Day 28
Waist circumference	Waist circumference will be measured in cm	Baseline, Day 28
Systolic Blood Pressure	Systolic blood pressure in mmHg	Baseline, Day 28
Diastolic Blood Pressure	Diastolic blood pressure in mmHg	Baseline, Day 28
Hand Grip Strength	Measured using a dynamometer in kg, taken in triplicate	Baseline, Day 28
Tender and Swollen Joint Count (TSJC)	44 joints assessed by a rheumatologist	Baseline, Day 28
Physician Global Assessment of Disease Activity	Severity measured on a scale from 0 to 10	Baseline, Day 28
Routine Assessment of Patient Index Data 3 (RAPID 3)	Disease activity index calculated from a short and questionnaire	Baseline, Day 28
Simple Disease Activity Index (SDAI)	A score that determines severity of rheumatoid arthritis using clinical and laboratory data	Baseline, Day 28
Clinical Disease Activity Index (CDAI)	A score that determines severity of rheumatoid arthritis using only clinical data	Baseline, Day 28
Disease Activity Score-28- C-Reactive Protein (DAS28-CRP)	A score that describes severity of rheumatoid arthritis using clinical data and CRP	Baseline, Day 28
Dietary Inflammatory Index	A score calculated from dietary data, to establish the inflammatory potential of an individual's diet.	Baseline, Day 28

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Liam O'Neil, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Curcumin
• Other Study ID Numbers: HH1-168004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No