Effect of Vitamin d and Omega 3 on Osteocalcin

July 12, 2020 updated by: Applied Science Private University

Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Plasma Osteocalcin Levels : a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency

Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the OCN levels.

This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on PLASMA OCN levels in females and males with vitamin D deficiency (VDD).

This randomized, controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks,separately and with each other, on the plasma levels of OCN and 25-hydroxy vitamin D (25OHD).

This study was conducted during winter in 86 healthy Jordanian females and males with VDD with a mean age of (40± 10) years.

Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • Applied Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml).

Exclusion Criteria:

  • People who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation.
  • People with bone disorders also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vitamin d3 group
weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks
Other: control
no intervention
Dietary supplement: vitamin D3
50,000 IU VD3 / week for 8 weeks
Dietary supplement: omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
Dietary supplement: vitamin D3 and omega-3 fatty acid
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
EXPERIMENTAL: omega3-Fatty Acid group
1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
Other: control
no intervention
Dietary supplement: vitamin D3
50,000 IU VD3 / week for 8 weeks
Dietary supplement: omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
Dietary supplement: vitamin D3 and omega-3 fatty acid
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
EXPERIMENTAL: VD3 and Omega-3FA group
50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily
Other: control
no intervention
Dietary supplement: vitamin D3
50,000 IU VD3 / week for 8 weeks
Dietary supplement: omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
Dietary supplement: vitamin D3 and omega-3 fatty acid
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
NO_INTERVENTION: Control group
NO INTERVENTION

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vitamin d3 levels
Time Frame: 8 weeks
Plasma levels of 25-hydroxyvitamin D
8 weeks
osteocalcin levels
Time Frame: 8 weeks
plasma osteocalcin levels
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTH
Time Frame: 8 weeks
Plasma concentrations of PTH
8 weeks
calcium
Time Frame: 8 weeks
plasma Ca levels
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Science Private University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (ACTUAL)

July 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 12, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRGS-2014-2015-165-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

when summary data are published

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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