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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04307784

Enrollment

115

Registered

2020-03-13

Start date

2020-03-10

Completion date

2020-06-30

Last updated

2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTVD3

VD3 (50.000 IU/week) for 8 weeks

DIETARY_SUPPLEMENTOmega-3FA

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

DIETARY_SUPPLEMENTVD3 and Omega-3FA

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

OTHERControl

No intervention is given

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C	8 weeks	Concentration

Secondary

Measure	Time frame	Description
Plasma Concentration of PTH and Calcium	8 weeks	Concentration

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026