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

NCT ID: NCT04307784

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vitamin D3 alone Group

Treated with VD3 (50.000 IU/week)

Group Type EXPERIMENTAL

VD3

Intervention Type DIETARY_SUPPLEMENT

VD3 (50.000 IU/week) for 8 weeks

Omaga-3 alone Group

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

Group Type EXPERIMENTAL

Omega-3FA

Intervention Type DIETARY_SUPPLEMENT

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

Vitamin D3 and Omega-3 Combination, Group

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.

Group Type EXPERIMENTAL

VD3 and Omega-3FA

Intervention Type DIETARY_SUPPLEMENT

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

Control Group

No intervention was given.

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

No intervention is given

Interventions

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VD3

VD3 (50.000 IU/week) for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Omega-3FA

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

Intervention Type DIETARY_SUPPLEMENT

VD3 and Omega-3FA

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

Intervention Type DIETARY_SUPPLEMENT

Control

No intervention is given

Intervention Type OTHER

Other Intervention Names

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nothing

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Applied Science Private University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud S Abu-samak, PhD

Role: PRINCIPAL_INVESTIGATOR

Applied Science Private University (ASU)

Locations

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Applied Science University

Amman, , Jordan

Site Status

Countries

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Jordan

Related Links

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

C-peptide: new findings and therapeutic possibilities.

Other Identifiers

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DRGS-2014-2015-165-6

Identifier Type: -

Identifier Source: org_study_id

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