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

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

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: VD3; Dietary supplement: omega 3- FA; Dietary supplement: VD3 and omega- 3FA; Other: no intervention

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 Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Applied Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Applied Science Private University
• Investigators: Principal Investigator: Mahmoud S Abu-Samak, PhD, Applied Science University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2019
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: vitamin D3; Lipid profile; Vitamin D Deficiency; omega-3 fatty acids; oxidized low density Lipoprotein
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: DRGS-2014-2015-165-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underline results in a publication
• IPD Sharing Time Frame: when summary data will published
• IPD Sharing Access Criteria: open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No