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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2020-01-01

Brief Summary

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The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency

Detailed Description

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Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density lipoprotein

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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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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VD3 group

dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks

Group Type EXPERIMENTAL

VD3

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

omega 3- FA

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

VD3 and omega- 3FA

Intervention Type DIETARY_SUPPLEMENT

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

Group Type OTHER

no intervention

Intervention Type OTHER

no intervention is given

Interventions

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VD3

VD3 50000 IU/ week for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

omega 3- FA

Omega 3 FA group 300 mg once daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

VD3 and omega- 3FA

50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

no intervention

no intervention is given

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD \<25 ng/ ml)

Exclusion Criteria

* Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations
Minimum Eligible Age

22 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Applied Science Private University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Jordan

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.

Reference Type BACKGROUND
PMID: 21986389 (View on PubMed)

Other Identifiers

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DRGS-2014-2015-165-2

Identifier Type: -

Identifier Source: org_study_id

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