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出境医 / 临床实验 / 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

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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : July 10, 2019
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : January 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
control group
no intervention was given
 Other: no intervention
no intervention is given
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  1. PTH [ Time Frame: 8 weeks ]
    serum level of PTH

  2. Calcium and Phosphorus [ Time Frame: 8 weeks ]
    serum level of Calcium and Phosphorus


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
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Jordan
Applied Science University
Amman, Jordan
Sponsors and Collaborators
Applied Science Private University
Investigators
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Principal Investigator: Mahmoud S Abu-Samak, PhD Applied science university
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE July 10, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • VD 3 [ Time Frame: 8 weeks ]
    Serum level of 25-hydroxyvitamin D
  • Total Cholesterol [ Time Frame: 8 weeks ]
    serum level of total cholesterol
  • HDL Cholesterol [ Time Frame: 8 weeks ]
    serum level of HDL Cholesterol
  • LDL Cholesterol [ Time Frame: 8 weeks ]
    serum level of LDL Cholesterol
  • triglycerides [ Time Frame: 8 weeks ]
    serum level of triglycerides
  • oxidized LDL [ Time Frame: 8 weeks ]
    serum level of oxidized LDL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • PTH [ Time Frame: 8 weeks ]
    serum level of PTH
  • Calcium and Phosphorus [ Time Frame: 8 weeks ]
    serum level of Calcium and Phosphorus
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Dietary Supplement: VD3
    VD3 50000 IU/ week for 8 weeks
  • Dietary Supplement: omega 3- FA
    Omega 3 FA group 300 mg 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: no intervention
    no intervention is given
Study Arms  ICMJE
  • Experimental: VD3 group
    dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
    Intervention: Dietary Supplement: VD3
  • 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
    Intervention: Dietary Supplement: omega 3- FA
  • 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
    Intervention: Dietary Supplement: VD3 and omega- 3FA
  • control group
    no intervention was given
    Intervention: Other: no intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2020) 		111
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		120
Actual Study Completion Date  ICMJE January 1, 2020
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005573
Other Study ID Numbers  ICMJE DRGS-2014-2015-165-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all IPD that underline results in a publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: when summary data will published
Access Criteria: open access
Responsible Party Applied Science Private University
Study Sponsor  ICMJE Applied Science Private University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mahmoud S Abu-Samak, PhD Applied science university
PRS Account Applied Science Private University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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