The Effect of Omega 3 on 25 Hydroxyvitamin D | NCT04174625

Studies
The Effect of Omega 3 on 25 Hydroxyvitamin D

NCT04174625

Sponsor

Applied Science Private University

Status

Completed

Last Update Posted

Feb 24, 2022Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

25-hydroxyvitamin D Levels

Interventions

Dietary Supplement: Omega3-FA

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2020Actual

Primary Completion Date

Jul 17, 2021Actual

Completion Date

Dec 15, 2021Actual

First Submitted Date

Nov 20, 2019

First Submission Date that Met QC Criteria

Nov 21, 2019

First Posted Date

Nov 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2022

Last Update Posted Date

Feb 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dietary Supplement: Omega3-FA	Dietary Supplement	Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks	Control group Omega3-FA group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
serum concentration of calcium	mg/dl	8 weeks
serum concentration of phosphate	mg/dl	8 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud S Abu-Samak, PhD	Department of Clinical Pharmacy and Therapeutics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahmoud S Abu-Samak		Amman			Jordan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

all IPD that underlie results in a publication

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

after six months

Access Criteria

open access

URL

Not provided