Effect of Vitamin d and Omega 3 on Osteocalcin

NCT ID: NCT04005612

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-02-01

Brief Summary

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

Detailed Description

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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 .

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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vitamin d3 group

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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks

omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

300 mg of omega 3-FA once daily for 8 weeks

vitamin D3 and omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks

control

Intervention Type OTHER

no intervention

omega3-Fatty Acid group

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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks

omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

300 mg of omega 3-FA once daily for 8 weeks

vitamin D3 and omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks

control

Intervention Type OTHER

no intervention

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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks

omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

300 mg of omega 3-FA once daily for 8 weeks

vitamin D3 and omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks

control

Intervention Type OTHER

no intervention

Control group

NO INTERVENTION

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vitamin D3

50,000 IU VD3 / week for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

omega-3 fatty acid

300 mg of omega 3-FA once daily for 8 weeks

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

control

no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Applied Science Private University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud S Abu-Samak, PhD

Role: PRINCIPAL_INVESTIGATOR

Applied Science Private University

Locations

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Applied Science University

Amman, , Jordan

Site Status

Countries

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Jordan

References

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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.

Reference Type BACKGROUND
PMID: 18400738 (View on PubMed)

Other Identifiers

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DRGS-2014-2015-165-3

Identifier Type: -

Identifier Source: org_study_id

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