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Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735303
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Applied Science Private University

Brief Summary:
The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: VD3 group Dietary Supplement: omega 3 FA group Dietary Supplement: VD3 and omega- 3FA group Other: control group Not Applicable

Detailed Description:

Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels 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 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Combined Effect of Vitamin D3 and Omega-3 Supplements on Serum Leptin and Glycated Hemoglobin (Hb A1C) Levels in Jordanian People With Vitamin D Deficiency.
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VD3 group
dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
Dietary Supplement: VD3 group
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 group
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 group
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

Experimental: control group
no intervention was given
Other: control group
no intervention was given




Primary Outcome Measures :
  1. VD 3 [ Time Frame: 8 weeks ]
    Serum level of 25-hydroxyvitamin D

  2. leptin [ Time Frame: 8 weeks ]
    serum level of leptin

  3. HbA1C [ Time Frame: 8 weeks ]
    plasma concentration of HbA1C



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Ages Eligible for Study:   25 Years to 55 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:

  • Blood disorders including
  • thalassemia
  • sickle cell disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735303


Locations
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Jordan
Applied Science University
Amman, Jordan, 11931
Sponsors and Collaborators
Applied Science Private University
Investigators
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Principal Investigator: Mahmoud S Abu-Samak, PhD Applied Science Private University
Publications of Results:
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Responsible Party: Applied Science Private University
ClinicalTrials.gov Identifier: NCT03735303    
Other Study ID Numbers: DRGS-4-2018
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underline results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: when summary data will published
Access Criteria: open access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Applied Science Private University:
vitamin D3
vitamin D deficiency
leptin
A1C
omega-3 fatty acid
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders