Clincosm LogoSign in Get a demo

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

Sponsor
Applied Science Private University (Other)
Overall Status
Completed
CT.gov ID
NCT04174625
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
12.6
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary Supplement: Omega3-FA
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Omega 3 Supplementations on Serum 25 Hydroxyvitamin D Levels
Actual Study Start Date :
Nov 25, 2020
Actual Primary Completion Date :
Jul 17, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. serum concentrations of 25-hydroxyvitamin D [8 weeks]

      ng/ml

    2. serum concentrations of PTH [8 weeks]

      pg/mL

    Other Outcome Measures

    1. serum concentration of calcium [8 weeks]

      mg/dl

    2. serum concentration of phosphate [8 weeks]

      mg/dl

    3. serum ALT [8 weeks]

      U/L

    4. Serum urea [8 weeks]

      mg/dL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 66 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mahmoud S Abu-Samak Amman Jordan

    Sponsors and Collaborators

    • Applied Science Private University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Suleiman Abu-Samak, Prof.Dr. Mahmoud Suleiman Abu-Samak, Applied Science Private University
    ClinicalTrials.gov Identifier:
    NCT04174625
    Other Study ID Numbers:
    • DRGS-2014-2015-165-5
    First Posted:
    Nov 22, 2019
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahmoud Suleiman Abu-Samak, Prof.Dr. Mahmoud Suleiman Abu-Samak, Applied Science Private University
    omega 3
    25 hydroxyvitamin D
    25OHD
    Vitamin D

    Study Results

    No Results Posted as of Feb 24, 2022