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

July 16, 2019 updated by: Applied Science Private University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11931
        • Applied Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

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:

  • Blood disorders including
  • thalassemia
  • sickle cell disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VD 3
Time Frame: 8 weeks
Serum level of 25-hydroxyvitamin D
8 weeks
leptin
Time Frame: 8 weeks
serum level of leptin
8 weeks
HbA1C
Time Frame: 8 weeks
plasma concentration of HbA1C
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Science Private University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRGS-4-2018

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
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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