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

Applied Science Private University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Other: Control; Dietary Supplement: VD3 and Omega-3FA; Dietary Supplement: VD3; Dietary Supplement: Omega-3FA

Study type: Interventional

Funder types: Other

Identifiers

NCT04307784

DRGS-2014-2015-165-6

Details and patient eligibility

About

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

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 30 to 64 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 4 patient groups

Vitamin D3 alone Group

Experimental group

Description:

Treated with VD3 (50.000 IU/week)

Treatment:

Dietary Supplement: VD3

Omaga-3 alone Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Omega-3FA

Vitamin D3 and Omega-3 Combination, Group

Experimental group

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.

Treatment:

Dietary Supplement: VD3 and Omega-3FA

Control Group

Experimental group

Description:

No intervention was given.

Treatment:

Other: Control