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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: no intervention; Dietary Supplement: omega 3- FA; Dietary Supplement: VD3; Dietary Supplement: VD3 and omega- 3FA

• Registration Number: NCT04005573
• Lead Sponsor: Applied Science Private University

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

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-07-10
• Primary Completion: 2019-11-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	no intervention	no intervention was given
omega 3- FA group	omega 3- FA	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 group	VD3	dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
VD3 and omega 3 FA group	VD3 and omega- 3FA	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

Primary Outcome Measures

Name	Time	Method
LDL Cholesterol	8 weeks	serum level of LDL Cholesterol
HDL Cholesterol	8 weeks	serum level of HDL Cholesterol
VD 3	8 weeks	Serum level of 25-hydroxyvitamin D
triglycerides	8 weeks	serum level of triglycerides
Total Cholesterol	8 weeks	serum level of total cholesterol
oxidized LDL	8 weeks	serum level of oxidized LDL

Secondary Outcome Measures

Name	Time	Method
PTH	8 weeks	serum level of PTH
Calcium and Phosphorus	8 weeks	serum level of Calcium and Phosphorus

Trial Locations

Locations (1)

Applied Science University; 🇯🇴 Amman, Jordan