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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005573
• Other study ID #: DRGS-2014-2015-165-2
• Status: Completed
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2019
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• VD3
VD3 50000 IU/ week for 8 weeks
• omega 3- FA
Omega 3 FA group 300 mg once daily for 8 weeks
• VD3 and omega- 3FA
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

Other:
• no intervention
no intervention is given

Locations

Country	Name	City	State
Jordan	Applied Science University	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VD 3	Serum level of 25-hydroxyvitamin D	8 weeks
Primary	Total Cholesterol	serum level of total cholesterol	8 weeks
Primary	HDL Cholesterol	serum level of HDL Cholesterol	8 weeks
Primary	LDL Cholesterol	serum level of LDL Cholesterol	8 weeks
Primary	triglycerides	serum level of triglycerides	8 weeks
Primary	oxidized LDL	serum level of oxidized LDL	8 weeks
Secondary	PTH	serum level of PTH	8 weeks
Secondary	Calcium and Phosphorus	serum level of Calcium and Phosphorus	8 weeks