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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Omega-3FA; Dietary Supplement: VD3; Dietary Supplement: VD3 and Omega-3FA; Other: Control

• Registration Number: NCT04307784
• Lead Sponsor: Applied Science Private University

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.

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Primary Completion: 2020-06-10
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-12
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omaga-3 alone Group	Omega-3FA	Treated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.
Vitamin D3 alone Group	VD3	Treated with VD3 (50.000 IU/week)
Vitamin D3 and Omega-3 Combination, Group	VD3 and Omega-3FA	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.
Control Group	Control	No intervention was given.

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C	8 weeks	Concentration

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of PTH and Calcium	8 weeks	Concentration

Trial Locations

Locations (1)

Applied Science University; 🇯🇴 Amman, Jordan