The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control
NCT ID: NCT04307784
Last Updated: 2020-07-14
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
115 participants
INTERVENTIONAL
2020-03-10
2020-06-30
Brief Summary
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Detailed Description
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This study will be conducted to investigate the effects of (VD3) alone and as a combination with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D deficiency (VDD).
This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/ weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out during winter on 120 healthy Jordanian males and females with VDD with age range (25-50) years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine aminotransferase) and Urea were assessed at baseline and at 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 alone Group
Treated with VD3 (50.000 IU/week)
VD3
VD3 (50.000 IU/week) for 8 weeks
Omaga-3 alone Group
Treated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.
Omega-3FA
Omaga-3FA (300 mg/day) for 8 weeks
Vitamin D3 and Omega-3 Combination, Group
Treated with 50.000 IU VD3 per week and 1000 mg wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.
VD3 and Omega-3FA
VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks
Control Group
No intervention was given.
Control
No intervention is given
Interventions
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VD3
VD3 (50.000 IU/week) for 8 weeks
Omega-3FA
Omaga-3FA (300 mg/day) for 8 weeks
VD3 and Omega-3FA
VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks
Control
No intervention is given
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a medical diagnosis of VDD
Exclusion Criteria
* Documented history of allergic reactions to Omega-3FA supplementations
30 Years
64 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 (ASU)
Locations
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Applied Science University
Amman, , Jordan
Countries
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Related Links
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C-peptide: new findings and therapeutic possibilities.
Other Identifiers
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DRGS-2014-2015-165-6
Identifier Type: -
Identifier Source: org_study_id
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