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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307784
• Other study ID #: DRGS-2014-2015-165-6
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 30, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• VD3
VD3 (50.000 IU/week) for 8 weeks
• Omega-3FA
Omaga-3FA (300 mg/day) for 8 weeks
• VD3 and Omega-3FA
VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks

Other:
• Control
No intervention is given

Locations

Country	Name	City	State
Jordan	Applied Science University	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C	Concentration	8 weeks
Secondary	Plasma Concentration of PTH and Calcium	Concentration	8 weeks

External Links

•   C-peptide: new findings and therapeutic possibilities.