NCT05414838: PASCOD

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

Completed NA Last updated 28 September 2023

What this trial tests

NA trial testing Curcumin, Omega-3 and Vitamin-D (COD) in Healthy Participants in 50 participants. Completed in 27 September 2023.

Timeline

11 July 2022

Primary endpoint
26 September 2023

27 September 2023

Quick facts

Lead sponsor	University of Manitoba
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	11 July 2022
Primary completion	26 September 2023
Estimated completion	27 September 2023
Sites	1 location across Canada

Drugs / interventions tested

• Curcumin, Omega-3 and Vitamin-D (COD)

Conditions studied

• Healthy Participants — all drugs for Healthy Participants →

Sponsor

University of Manitoba

Who can join

Adults 18 to 49, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Cellular Senescence in Disease Progression and Transplantation: Immune Cells and Solid Organs.
   Kirchner VA, Badshah JS, Hong SK, Martinez O, et al · · 2024 · cited 8× · PMID 37953486 · DOI 10.1097/tp.0000000000004838