The Effect of Omega 3 on 25 Hydroxyvitamin D (n-3FAon25OHD)

February 23, 2022 updated by: Mahmoud Suleiman Abu-Samak, Applied Science Private University

The Effect of Omega 3 Supplementations on Serum 25 Hydroxyvitamin D Levels

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • Mahmoud S Abu-Samak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 66 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Omega3-FA group
Omega3-FA group 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
Dietary supplement: Dietary Supplement: Omega3-FA
Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks
Other Names:
  • n-3FA
EXPERIMENTAL: Control group
VD3 group 50,000 IU/week
Dietary supplement: Dietary Supplement: Omega3-FA
Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks
Other Names:
  • n-3FA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum concentrations of 25-hydroxyvitamin D
Time Frame: 8 weeks
ng/ml
8 weeks
serum concentrations of PTH
Time Frame: 8 weeks
pg/mL
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum concentration of calcium
Time Frame: 8 weeks
mg/dl
8 weeks
serum concentration of phosphate
Time Frame: 8 weeks
mg/dl
8 weeks
serum ALT
Time Frame: 8 weeks
U/L
8 weeks
Serum urea
Time Frame: 8 weeks
mg/dL
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Science Private University

Investigators

  • Principal Investigator: Mahmoud S Abu-Samak, PhD, Department of Clinical Pharmacy and Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 25, 2020

Primary Completion (ACTUAL)

July 17, 2021

Study Completion (ACTUAL)

December 15, 2021

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (ACTUAL)

November 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DRGS-2014-2015-165-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

after six months

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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