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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
VD3 group
omega 3 FA group
VD3 and omega- 3FA group
control group
Sponsored by
Applied Science Private University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring vitamin D3, vitamin D deficiency, leptin, A1C, omega-3 fatty acid

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Applied Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

VD3 group

omega 3- FA group

VD3 and omega 3 FA group

control group

Arm Description

dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks

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 : 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

no intervention was given

Outcomes

Primary Outcome Measures

VD 3
Serum level of 25-hydroxyvitamin D
leptin
serum level of leptin
HbA1C
plasma concentration of HbA1C

Secondary Outcome Measures

Full Information

First Posted
November 7, 2018
Last Updated
July 16, 2019
Sponsor
Applied Science Private University
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1. Study Identification

Unique Protocol Identification Number
NCT03735303
Brief Title
Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Science Private University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D3, vitamin D deficiency, leptin, A1C, omega-3 fatty acid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VD3 group
Arm Type
Experimental
Arm Description
dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks
Arm Title
omega 3- FA group
Arm Type
Experimental
Arm Description
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
Arm Title
VD3 and omega 3 FA group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Experimental
Arm Description
no intervention was given
Intervention Type
Dietary Supplement
Intervention Name(s)
VD3 group
Intervention Description
VD3 50000 IU/ week for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
omega 3 FA group
Intervention Description
omega 3 FA group 300 mg once daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
VD3 and omega- 3FA group
Intervention Description
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
no intervention was given
Primary Outcome Measure Information:
Title
VD 3
Description
Serum level of 25-hydroxyvitamin D
Time Frame
8 weeks
Title
leptin
Description
serum level of leptin
Time Frame
8 weeks
Title
HbA1C
Description
plasma concentration of HbA1C
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abu-Samak, PhD
Organizational Affiliation
Applied Science Private University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Science University
City
Amman
ZIP/Postal Code
11931
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
21492489
Citation
Ross AC. The 2011 report on dietary reference intakes for calcium and vitamin D. Public Health Nutr. 2011 May;14(5):938-9. doi: 10.1017/S1368980011000565. No abstract available.
Results Reference
result

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

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