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

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: VD3; Dietary supplement: Omega-3FA; Dietary supplement: VD3 and Omega-3FA; Other: 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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Applied Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin D3 alone Group; Treated with VD3 (50.000 IU/week)	Dietary supplement: VD3; VD3 (50.000 IU/week) for 8 weeks
EXPERIMENTAL: Omaga-3 alone Group; Treated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily.	Dietary supplement: Omega-3FA; Omaga-3FA (300 mg/day) for 8 weeks
EXPERIMENTAL: Vitamin D3 and Omega-3 Combination, Group; 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.	Dietary supplement: VD3 and Omega-3FA; VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks
EXPERIMENTAL: Control Group; No intervention was given.	Other: Control; No intervention is given; Other Names: nothing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of PTH and Calcium	Concentration	8 weeks

Collaborators and Investigators

• Sponsor: Applied Science Private University
• Investigators: Principal Investigator: Mahmoud S Abu-samak, PhD, Applied Science Private University (ASU)

Publications and helpful links

Helpful Links

• C-peptide: new findings and therapeutic possibilities.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2020
• Primary Completion (ACTUAL): June 10, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (ACTUAL): March 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Insulin resistance; vitamin D3; Vitamin D Deficiency; omega-3 fatty acids; C-peptide; HbA1C; A1C; glycated Hemoglubine; VD3
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: DRGS-2014-2015-165-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underline results in a publication.
• IPD Sharing Time Frame: When summary data are published
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No