Study Results
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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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-11-01
2020-02-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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vitamin d3 group
weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks
vitamin D3
50,000 IU VD3 / week for 8 weeks
omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
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
control
no intervention
omega3-Fatty Acid group
1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily
vitamin D3
50,000 IU VD3 / week for 8 weeks
omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
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
control
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
vitamin D3
50,000 IU VD3 / week for 8 weeks
omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
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
control
no intervention
Control group
NO INTERVENTION
No interventions assigned to this group
Interventions
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vitamin D3
50,000 IU VD3 / week for 8 weeks
omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
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
control
no intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* People with bone disorders also excluded.
22 Years
50 Years
ALL
Yes
Sponsors
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Applied Science Private University
OTHER
Responsible Party
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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
Countries
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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.
Other Identifiers
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DRGS-2014-2015-165-3
Identifier Type: -
Identifier Source: org_study_id
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