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The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Jordan

Study Type

Interventional

Intervention

VD3

Omega-3FA

VD3 and Omega-3FA

Control

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D Deficiency, vitamin D3, omega-3 fatty acids, glycated Hemoglubine, C-peptide, Insulin resistance, VD3, A1C, HbA1C

Eligibility Criteria

30 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged (30-64)
Have a medical diagnosis of VDD

Exclusion Criteria:

Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia).
Documented history of allergic reactions to Omega-3FA supplementations

Sites / Locations

Applied Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Vitamin D3 alone Group

Omaga-3 alone Group

Vitamin D3 and Omega-3 Combination, Group

Control Group

Arm Description

Treated with VD3 (50.000 IU/week)

Treated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.

Treated with 50.000 IU VD3 per week and 1000 mg wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.

No intervention was given.

Outcomes

Primary Outcome Measures

Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C

Concentration

Secondary Outcome Measures

Plasma Concentration of PTH and Calcium

Concentration

Full Information

NCT ID

NCT04307784

First Posted

March 11, 2020

Last Updated

July 12, 2020

Sponsor

Applied Science Private University

1. Study Identification

Unique Protocol Identification Number

NCT04307784

Brief Title

The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control

Official Title

The Effects of Vitamin D3 Supplementation Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control; A Randomized Controlled Trial in People With Vitamin D Deficiency

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 10, 2020 (Actual)

Primary Completion Date

June 10, 2020 (Actual)

Study Completion Date

June 30, 2020 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control

Detailed Description

The data bout the effects of Vitamin D3 (VD3) alone and as a combination with omega-3 fatty acids (Omega-3FA) on the association between C-peptide (CP) and the glycated hemoglobin (HbA1c) is scarce, conflicting and nothing published in the literature review on the combined effect of VD3 and Omega-3FA as a combination on the association of CP with glycemic control. This study will be conducted to investigate the effects of (VD3) alone and as a combination with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D deficiency (VDD). This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/ weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out during winter on 120 healthy Jordanian males and females with VDD with age range (25-50) years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine aminotransferase) and Urea were assessed at baseline and at the end of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

Vitamin D Deficiency, vitamin D3, omega-3 fatty acids, glycated Hemoglubine, C-peptide, Insulin resistance, VD3, A1C, HbA1C

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3 alone Group

Arm Type

Experimental

Arm Description

Treated with VD3 (50.000 IU/week)

Arm Title

Omaga-3 alone Group

Arm Type

Experimental

Arm Description

Treated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.

Arm Title

Vitamin D3 and Omega-3 Combination, Group

Arm Type

Experimental

Arm Description

Treated with 50.000 IU VD3 per week and 1000 mg wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.

Arm Title

Control Group

Arm Type

Experimental

Arm Description

No intervention was given.

Intervention Type

Dietary Supplement

Intervention Name(s)

VD3

Intervention Description

VD3 (50.000 IU/week) for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3FA

Intervention Description

Omaga-3FA (300 mg/day) for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

VD3 and Omega-3FA

Intervention Description

VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks

Intervention Type

Other

Intervention Name(s)

Control

Other Intervention Name(s)

nothing

Intervention Description

No intervention is given

Primary Outcome Measure Information:

Title

Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C

Description

Concentration

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Plasma Concentration of PTH and Calcium

Description

Concentration

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged (30-64) Have a medical diagnosis of VDD Exclusion Criteria: Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia). Documented history of allergic reactions to Omega-3FA supplementations

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud S Abu-samak, PhD

Organizational Affiliation

Applied Science Private University (ASU)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Applied Science University

City

Amman

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 are published

IPD Sharing Access Criteria

Open access

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/25648391

Description

C-peptide: new findings and therapeutic possibilities.

Learn more about this trial

The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control

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