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

Sponsor

Applied Science Private University (Other)

Overall Status

Completed

CT.gov ID

NCT04005573

Collaborator

(none)

111

Enrollment

Location

Arms

5.7

Actual Duration (Months)

19.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Dietary Supplement: VD3 Dietary Supplement: omega 3- FA Dietary Supplement: VD3 and omega- 3FA Other: no intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jul 10, 2019

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

PTH [8 weeks]
serum level of PTH
Calcium and Phosphorus [8 weeks]
serum level of Calcium and Phosphorus

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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