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Effect of Vitamin d and Omega 3 on Osteocalcin

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
vitamin D3
omega-3 fatty acid
vitamin D3 and omega-3 fatty acid
control
Sponsored by
Applied Science Private University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D Deficiency, plama osteocalcin, omega-3 fatty acids

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Applied Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

vitamin d3 group

omega3-Fatty Acid group

VD3 and Omega-3FA group

Control group

Arm Description

weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks

1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily

50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily

NO INTERVENTION

Outcomes

Primary Outcome Measures

vitamin d3 levels
Plasma levels of 25-hydroxyvitamin D
osteocalcin levels
plasma osteocalcin levels

Secondary Outcome Measures

PTH
Plasma concentrations of PTH
calcium
plasma Ca levels

Full Information

First Posted
July 1, 2019
Last Updated
July 12, 2020
Sponsor
Applied Science Private University
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1. Study Identification

Unique Protocol Identification Number
NCT04005612
Brief Title
Effect of Vitamin d and Omega 3 on Osteocalcin
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Science Private University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D Deficiency, plama osteocalcin, omega-3 fatty acids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin d3 group
Arm Type
Experimental
Arm Description
weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks
Arm Title
omega3-Fatty Acid group
Arm Type
Experimental
Arm Description
1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
Arm Title
VD3 and Omega-3FA group
Arm Type
Experimental
Arm Description
50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily
Arm Title
Control group
Arm Type
No Intervention
Arm Description
NO INTERVENTION
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Intervention Description
50,000 IU VD3 / week for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fatty acid
Intervention Description
300 mg of omega 3-FA once daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3 and omega-3 fatty acid
Intervention Description
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
vitamin d3 levels
Description
Plasma levels of 25-hydroxyvitamin D
Time Frame
8 weeks
Title
osteocalcin levels
Description
plasma osteocalcin levels
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
PTH
Description
Plasma concentrations of PTH
Time Frame
8 weeks
Title
calcium
Description
plasma Ca levels
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abu-Samak, PhD
Organizational Affiliation
Applied Science Private University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Science University
City
Amman
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
18400738
Citation
Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
Results Reference
background

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Effect of Vitamin d and Omega 3 on Osteocalcin

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