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Completed

NCT Number: NCT04005573

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

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

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

22 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Science University

Amman, Jordan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VD3

Dietary Supplement

VD3 50000 IU/ week for 8 weeks

omega 3- FA

Dietary Supplement

Omega 3 FA group 300 mg once daily for 8 weeks

VD3 and omega- 3FA

Dietary Supplement

50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

No intervention

Other

no intervention is given

Primary outcomes

  1. VD 3

    Time frame: 8 weeks

    Serum level of 25-hydroxyvitamin D

  2. Total Cholesterol

    Time frame: 8 weeks

    serum level of total cholesterol

  3. HDL Cholesterol

    Time frame: 8 weeks

    serum level of HDL Cholesterol

  4. LDL Cholesterol

    Time frame: 8 weeks

    serum level of LDL Cholesterol

  5. triglycerides

    Time frame: 8 weeks

    serum level of triglycerides

  6. oxidized LDL

    Time frame: 8 weeks

    serum level of oxidized LDL

Secondary outcomes

  1. PTH

    Time frame: 8 weeks

    serum level of PTH

  2. Calcium and Phosphorus

    Time frame: 8 weeks

    serum level of Calcium and Phosphorus

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 2, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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