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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VD3 group | Experimental | dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks |
|
| omega 3- FA group | Experimental | 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 |
|
| VD3 and omega 3 FA group | Experimental | 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 |
|
| control group | Other | no intervention was given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VD3 | Dietary Supplement | VD3 50000 IU/ week for 8 weeks |
| |
| omega 3- FA |
| Measure | Description | Time Frame |
|---|---|---|
| VD 3 | Serum level of 25-hydroxyvitamin D | 8 weeks |
| Total Cholesterol | serum level of total cholesterol | 8 weeks |
| HDL Cholesterol | serum level of HDL Cholesterol | 8 weeks |
| LDL Cholesterol | serum level of LDL Cholesterol | 8 weeks |
| triglycerides | serum level of triglycerides | 8 weeks |
| oxidized LDL | serum level of oxidized LDL | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PTH | serum level of PTH | 8 weeks |
| Calcium and Phosphorus | serum level of Calcium and Phosphorus | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud S Abu-Samak, PhD | Applied science university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Science University | Amman | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21986389 | Background | 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. |
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all IPD that underline results in a publication
when summary data will published
open access
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| Dietary Supplement |
Omega 3 FA group 300 mg once daily for 8 weeks |
|
| VD3 and omega- 3FA | Dietary Supplement | 50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks |
|
| no intervention | Other | no intervention is given |
|
| D009750 |
| Nutritional and Metabolic Diseases |