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临床试验/NCT04307784
NCT04307784已完成不适用

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

Applied Science Private University1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
1
主要终点
Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged (30-64)
  • Have a medical diagnosis of VDD

排除标准

  • 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

结局指标

主要结局

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

时间窗: 8 weeks

Concentration

次要结局

  • Plasma Concentration of PTH and Calcium(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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