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Completed

NCT Number: NCT04174625

The Effect of Omega 3 on 25 Hydroxyvitamin D

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

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Key information

Conditions

25-hydroxyvitamin D Levels

Age range

22 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahmoud S Abu-Samak

Amman, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Supplement: Omega3-FA

Dietary Supplement

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

Other names: n-3FA

Primary outcomes

  1. serum concentrations of 25-hydroxyvitamin D

    Time frame: 8 weeks

    ng/ml

  2. serum concentrations of PTH

    Time frame: 8 weeks

    pg/mL

Other outcomes

  1. serum concentration of calcium

    Time frame: 8 weeks

    mg/dl

  2. serum concentration of phosphate

    Time frame: 8 weeks

    mg/dl

  3. serum ALT

    Time frame: 8 weeks

    U/L

  4. Serum urea

    Time frame: 8 weeks

    mg/dL

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study title

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

Acronym: n-3FAon25OHD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.