The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: VD3
* Dietary Supplement: omega 3- FA
* Dietary Supplement: VD3 and omega- 3FA
* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VD3 group<br>dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks | Dietary Supplement: VD3<br>* VD3 50000 IU/ week for 8 weeks<br>|
| Experimental: omega 3- FA group<br>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: omega 3- FA<br>* Omega 3 FA group 300 mg once daily for 8 weeks<br>|
| Experimental: VD3 and omega 3 FA group<br>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 | Dietary Supplement: VD3 and omega- 3FA<br>* 50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks<br>|
| Other: control group<br>no intervention was given | Other: no intervention<br>* no intervention is given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH | serum level of PTH | 8 weeks | 
| Calcium and Phosphorus | serum level of Calcium and Phosphorus | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D3, Vitamin D Deficiency, Lipid profile, oxidized low density Lipoprotein, omega-3 fatty acids