NCT04307784

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Applied Science Private University · Academic / Other
• Sex: All
• Age: 30 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VD3	VD3 (50.000 IU/week) for 8 weeks
DIETARY_SUPPLEMENT	Omega-3FA	Omaga-3FA (300 mg/day) for 8 weeks
DIETARY_SUPPLEMENT	VD3 and Omega-3FA	VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks
OTHER	Control	No intervention is given

Timeline

• Start date: 2020-03-10
• Primary completion: 2020-06-10
• Completion: 2020-06-30
• First posted: 2020-03-13
• Last updated: 2020-07-14

Locations

1 site across 1 country: Jordan