The Effect of Omega 3 on 25 Hydroxyvitamin D

25-hydroxyvitamin D Levels Clinical Trial

— n-3FAon25OHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174625
• Other study ID #: DRGS-2014-2015-165-5
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2022
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 15, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• 25-hydroxyvitamin D Levels

Intervention

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

Locations

Country	Name	City	State
Jordan	Mahmoud S Abu-Samak	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum concentration of calcium	mg/dl	8 weeks
Other	serum concentration of phosphate	mg/dl	8 weeks
Other	serum ALT	U/L	8 weeks
Other	Serum urea	mg/dL	8 weeks
Primary	serum concentrations of 25-hydroxyvitamin D	ng/ml	8 weeks
Primary	serum concentrations of PTH	pg/mL	8 weeks