Back to resultsThe Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
VD3
omega 3- FA
VD3 and omega- 3FA
no intervention
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin D Deficiency focused on measuring vitamin D3, Vitamin D Deficiency, Lipid profile, oxidized low density Lipoprotein, omega-3 fatty acids
Eligibility Criteria
Inclusion Criteria:
- Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)
Exclusion Criteria:
- Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations
Sites / Locations
- Applied Science University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
VD3 group
omega 3- FA group
VD3 and omega 3 FA group
control group
Arm Description
dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
no intervention was given
Outcomes
Primary Outcome Measures
VD 3
Serum level of 25-hydroxyvitamin D
Total Cholesterol
serum level of total cholesterol
HDL Cholesterol
serum level of HDL Cholesterol
LDL Cholesterol
serum level of LDL Cholesterol
triglycerides
serum level of triglycerides
oxidized LDL
serum level of oxidized LDL
Secondary Outcome Measures
PTH
serum level of PTH
Calcium and Phosphorus
serum level of Calcium and Phosphorus
Full Information
NCT ID
NCT04005573
First Posted
July 1, 2019
Last Updated
January 10, 2020
Sponsor
Applied Science Private University
1. Study Identification
Unique Protocol Identification Number
NCT04005573
Brief Title
The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
Official Title
Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein: a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
January 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
The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency
Detailed Description
Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density lipoprotein
This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with vitamin D deficiency.
This randomized, controlled clinical trial will be 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 on lipid profile levels and oxidized low density lipoprotein
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D3, Vitamin D Deficiency, Lipid profile, oxidized low density Lipoprotein, 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
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VD3 group
Arm Type
Experimental
Arm Description
dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
Arm Title
omega 3- FA group
Arm Type
Experimental
Arm Description
dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
Arm Title
VD3 and omega 3 FA group
Arm Type
Experimental
Arm Description
dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks
Arm Title
control group
Arm Type
Other
Arm Description
no intervention was given
Intervention Type
Dietary Supplement
Intervention Name(s)
VD3
Intervention Description
VD3 50000 IU/ week for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
omega 3- FA
Intervention Description
Omega 3 FA group 300 mg once daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
VD3 and omega- 3FA
Intervention Description
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
no intervention is given
Primary Outcome Measure Information:
Title
VD 3
Description
Serum level of 25-hydroxyvitamin D
Time Frame
8 weeks
Title
Total Cholesterol
Description
serum level of total cholesterol
Time Frame
8 weeks
Title
HDL Cholesterol
Description
serum level of HDL Cholesterol
Time Frame
8 weeks
Title
LDL Cholesterol
Description
serum level of LDL Cholesterol
Time Frame
8 weeks
Title
triglycerides
Description
serum level of triglycerides
Time Frame
8 weeks
Title
oxidized LDL
Description
serum level of oxidized LDL
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
PTH
Description
serum level of PTH
Time Frame
8 weeks
Title
Calcium and Phosphorus
Description
serum level of Calcium and Phosphorus
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)
Exclusion Criteria:
Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abu-Samak, PhD
Organizational Affiliation
Applied science 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 underline results in a publication
IPD Sharing Time Frame
when summary data will published
IPD Sharing Access Criteria
open access
Citations:
PubMed Identifier
21986389
Citation
Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
Results Reference
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The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
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