Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04159532
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2019-11-06
Brief Title:
Comparative Study of Three Different Formulations of Omega-3 EPADHA
Sponsor:
SCF Pharma
Organization:
SCF Pharma
Study Overview
Official Title:
Comparative Bioavailability Study of Monoglyceride MAG Versus Triglyceride TG Versus Ethyl Ester EE Formulations of Eicosapentaenoic EPA and Docosahexaenoic DHA Acids Pilot Study IO3-03
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study aims at comparing the bioavailability of three different formulations of the omega-3 fatty acids eicosapentaenoic acid EPA and docosahexaenoic acid DHA The three formulations are ethyl ester EE triglyceride TG and monoglyceride MAG Thirty six 36 subjects will be divided in three groups of twelve subjects each equally divided in two study sites Each group will be taking one of the three different formulations of EPADHA at a daily dose of 15g for a period of 12 weeks Bioavailability will be measured through omega-3 index total content of EPA DHA in red blood cell membranes at baseline and every four weeks during treatment
Detailed Description:
This pilot study aims at comparing the bioavailability of three different formulations of a combination of omega-3 fatty acids eicosapentaenoic acid EPA and docosahexaenoic acid DHA in a standardized proportion of 460200 The three formulations are ethyl ester EE triglyceride TG and monoglyceride MAG versions of these fatty acids The formulations are prepared in a way to be similar in proportion of EPADHA in dose and in appearance Thirty six 36 subjects will be divided in three groups of twelve subjects each equally divided in two study sites The study will be randomized and double blinded Each group will be taking one of the three different formulations of EPADHA at a daily dose of 15g for a period of 12 weeks Bioavailability will be measured through omega-3 index total content of EPA DHA in red blood cell membranes at baseline and every four weeks during treatment After recruitment subjects will be seen in clinic every four weeks for a total of four 4 study visits during which a blood sample will be taken for analysis of the omega-3 index the investigational product will be returned and dispensed and finally adverse events will be noted and followed Treatment will be self-administered by subjects at home They will be asked to keep a journal of adverse events concomitant medication and to note every missed dose as well as significant changes in life habits smoking alcohol sports food diet and natural health products intake
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None