Status:
COMPLETED
Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements
Lead Sponsor:
University of Manitoba
Conditions:
Healthy Participants
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief 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) th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05414838
Start Date
July 11 2022
End Date
September 27 2023
Last Update
September 28 2023
Active Locations (1)
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1
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9