The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
NCT ID: NCT04005573
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2019-07-10
2020-01-01
Brief Summary
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Detailed Description
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This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with vitamin D deficiency.
This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on on lipid profile levels and oxidized low density lipoprotein
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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VD3 group
dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
VD3
VD3 50000 IU/ week for 8 weeks
omega 3- FA group
dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
omega 3- FA
Omega 3 FA group 300 mg once daily for 8 weeks
VD3 and omega 3 FA group
dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
VD3 and omega- 3FA
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
control group
no intervention was given
no intervention
no intervention is given
Interventions
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VD3
VD3 50000 IU/ week for 8 weeks
omega 3- FA
Omega 3 FA group 300 mg once daily for 8 weeks
VD3 and omega- 3FA
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
no intervention
no intervention is given
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
22 Years
64 Years
ALL
Yes
Sponsors
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Applied Science Private University
OTHER
Responsible Party
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Principal Investigators
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Mahmoud S Abu-Samak, PhD
Role: PRINCIPAL_INVESTIGATOR
Applied science university
Locations
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Applied Science University
Amman, , Jordan
Countries
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References
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Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
Other Identifiers
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DRGS-2014-2015-165-2
Identifier Type: -
Identifier Source: org_study_id
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