NCT04174625

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

November 20, 2019

Last Update Submit

February 23, 2022

Conditions

25-hydroxyvitamin D Levels

Keywords

omega 325 hydroxyvitamin D25OHDVitamin D

Outcome Measures

Primary Outcomes (2)

  • serum concentrations of 25-hydroxyvitamin D

    ng/ml

    8 weeks

  • serum concentrations of PTH

    pg/mL

    8 weeks

Other Outcomes (4)

  • serum concentration of calcium

    8 weeks

  • serum concentration of phosphate

    8 weeks

  • serum ALT

    8 weeks

  • +1 more other outcomes

Study Arms (2)

Omega3-FA group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

VD3 group 50,000 IU/week

Dietary Supplement: Dietary Supplement: Omega3-FA

Interventions

Dietary Supplement: Omega3-FADIETARY_SUPPLEMENT

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

Also known as: n-3FA
Control groupOmega3-FA group

Eligibility Criteria

Age22 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud S Abu-Samak

Amman, Jordan

Location

Study Officials

  • Mahmoud S Abu-Samak, PhD

    Department of Clinical Pharmacy and Therapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr. Mahmoud Suleiman Abu-Samak

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 22, 2019

Study Start

November 25, 2020

Primary Completion

July 17, 2021

Study Completion

December 15, 2021

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
after six months
Access Criteria
open access

Locations

JO(1)