The Effect of Omega 3 on 25 Hydroxyvitamin D

NCT ID: NCT04174625

Last Updated: 2022-02-24

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-25

Study Completion Date

2021-12-15

Brief Summary

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The effect of omega 3 fatty acid on serum 25-hydroxyvitamin D levels.

Detailed Description

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No data are available on the effect of omega 3 on serum 25-hydroxyvitamin D levels in Jordanian men and women.

This study was designed to investigate whether omega 3 supplementation has a potential effect on the reducing of serum 25-hydroxyvitamin D levels.

This randomized, placebo-controlled clinical trial (RCT) was designed to evaluate 300 mg omega-3FA daily for 2 months on serum levels of 25-hydroxyvitamin D levels. This RCT will be conducted on 80 to 90 Jordanian men and women aged 22 to 66 years. Baseline and follow-up levels for 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), calcium, phosphate, liver and kidney functions will be assayed.

Conditions

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25-hydroxyvitamin D Levels

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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Omega3-FA group

Omega3-FA group 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily

Group Type EXPERIMENTAL

Dietary Supplement: Omega3-FA

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks

Control group

VD3 group 50,000 IU/week

Group Type EXPERIMENTAL

Dietary Supplement: Omega3-FA

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks

Interventions

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Dietary Supplement: Omega3-FA

Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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n-3FA

Eligibility Criteria

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Inclusion Criteria

Age ≥18 years old

Male and female Jordanian ASU students and employees who live in Amman.

Informed written consent from the participant prior to the start of the study.

a serum 25(OH)D concentration between 10 and 70 ng/mL.

Exclusion Criteria

Any eligiable subject refuses to apply with informed written consent before the start of the study.

Men or women previously diagnosed with chronic diseases, including kidney disease or GIT problems.

Who are receiving vitamin D3 supplements (3 months before the start of the study) .

Pregnants,Breastfeeding females ,Females using hormonal contraceptives
Minimum Eligible Age

22 Years

Maximum Eligible Age

66 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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Mahmoud Suleiman Abu-Samak

Prof.Dr. Mahmoud Suleiman Abu-Samak

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud S Abu-Samak, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacy and Therapeutics

Locations

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Mahmoud S Abu-Samak

Amman, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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DRGS-2014-2015-165-5

Identifier Type: -

Identifier Source: org_study_id

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