Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
The table below explains what will be done at each study visit: Prior to Pre‐Registration Informed Consent. Questionnaire (asking about your risks for lung cancer, diet and medications including food supplement). Blood test for CRP level Prior to Registration/Randomization Blood test for CRP level (about 6 ml or 1 teaspoon) Pregnancy test (either blood or urine, for woman with childbearing potential only) Registration/Randomization Medical history Physical exam (Vital signs/Body height and weight) Receive 3 month supply of Omega 3 fatty acids for treatment first group. Blood tests for Fasting Blood insulin, etc (about 15 ml or 3 teaspoons) Receive a diary to record the amount of study medication you take each day and any side effects you may experience Week 2 telephone interview Ask about side effects you may be having Ask about other medications you may be taking Review study agent diary Month 1 visit (you will not be able to eat anything for 10 hours before the appointment) Blood test for Fasting Blood insulin, etc (15 ml or 3 teaspoons) ‐( All participants) Treatment Group: Ask about side effects you may be having Ask about other medications you may be taking Review study medication diary Month 2, 4, and 5 telephone interview Review diary Ask about side effects you may be having Ask about other medications you may be taking Month 3 visit (you will not be able to eat anything for 10 hours before the appointment) Physical exam with vital signs Repeat blood tests (about 15 ml or 3 teaspoons) (All participants) Treatment Group: Collect unused omega 3 (for treatment group) Receive next 3 month supply of omega 3 (for treatment group) Review study medication diary Ask about side effects you may be experiencing Ask about other medications you may be taking Month 6 or end of study visit (if left study early for any reason) Physical exam with vital signs Blood tests (about 15 ml or 3 teaspoons) ‐ All participants Treatment Group: Review and collect study agent diary Ask about side effects you may be having Ask about other medications you may be taking Month 7‐12 Cross over study Treatment group will become observation group Observation group will become treatment group with the same procedures in month 1 to 6
Epistemonikos ID: b84887a8705fde95ddc9c3eb47bce2268719ea24
First added on: May 22, 2024