NCT05414838

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-07-11
• Primary completion: 2023-09-26
• Completion: 2023-09-27
• First posted: 2022-06-10
• Last updated: 2023-09-28

Locations

1 site across 1 country: Canada