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Completed

NCT Number: 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 alone and in a combination with omega-3 on the association of C-peptide with glycemic control

Completed

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Key information

Age range

30 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Science University

Amman, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VD3

Dietary Supplement

VD3 (50.000 IU/week) for 8 weeks

Omega-3FA

Dietary Supplement

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

VD3 and Omega-3FA

Dietary Supplement

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

Control

Other

No intervention is given

Other names: nothing

Primary outcomes

  1. Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C

    Time frame: 8 weeks

    Concentration

Secondary outcomes

  1. Plasma Concentration of PTH and Calcium

    Time frame: 8 weeks

    Concentration

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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