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临床试验/NCT04682626
NCT04682626已完成不适用

Effect of Weekly High-dose Vitamin D3 Supplementation on the Association Between Circulatory FGF-23 and A1c Levels 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 150 人开始时间: 2020年12月25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
150
试验地点
1
主要终点
FGF-23

研究概览

简要总结

Among Jordanians, there is a high prevalence of T2DM. VDD has also spread rapidly in the past decade. Preliminary results of recent studies have shown that VD3 has a potential role in reducing FBG. Notably, the impact of VD3 supplementation on glycemic control in diabetics, as well as pre-diabetics, remains highly controversial. Some studies have shown that osteocalcin (OSC) is correlated with fat mass, sensitivity to and secretion of insulin, glucose metabolism, and glycemic variability. In mice, OSC injections improved insulin sensitivity and prevent obesity. A more recent study has found that T2DM was inversely correlated with osteocalcin levels . There is a strong correlation between OSC and fibroblastic factor -23 (FBF-23). Many recent studies have correlated FBF-23 as well as vitamin D levels with some of the pathological conditions such as chronic kidney failure, atherosclerosis, and diabetes. They stated possible interrelationships between insulin resistance, Hyperinsulinemia, and/or lower VD3 levels may lead to decreased serum FGF-23 concentrations in obese children and adolescents. Therefore, serum FGF-23 has been suggested to be a potential indicator of subclinical atherosclerosis in patients with gestational diabetes mellitus.

详细描述

Among Jordanians, there is a high prevalence of T2DM. VDD has also spread rapidly in the past decade. Preliminary results of recent studies have shown that VD3 has a potential role in reducing FBG. Notably, the impact of VD3 supplementation on glycemic control in diabetics, as well as pre-diabetics, remains highly controversial. Some studies have shown that osteocalcin (OSC) is correlated with fat mass, sensitivity to and secretion of insulin, glucose metabolism, and glycemic variability. In mice, OSC injections improved insulin sensitivity and prevent obesity. A more recent study has found that T2DM was inversely correlated with osteocalcin levels . There is a strong correlation between OSC and fibroblastic factor -23 (FBF-23). Many recent studies have correlated FBF-23 as well as vitamin D levels with some of the pathological conditions such as chronic kidney failure, atherosclerosis, and diabetes. They stated possible interrelationships between insulin resistance, Hyperinsulinemia, and/or lower VD3 levels may lead to decreased serum FGF-23 concentrations in obese children and adolescents. Therefore, serum FGF-23 has been suggested to be a potential indicator of subclinical atherosclerosis in patients with gestational diabetes mellitus. Based on these data, we expect that a high dose of vitamin D will significantly influence the association between A1c with FGF-23 levels in people with vitamin D deficiency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Single (Participant)

入排标准

年龄范围
22 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria included males and females in the age range of 22-55 years with a medical diagnosis of vitamin D deficiency.

排除标准

  • subjects with any chronic disease such as kidney failure, CVD, diabetes, blood disorders, or immune problems, including autoimmune diseases, chronic or severe infections will be excluded.

结局指标

主要结局

FGF-23

时间窗: 10 weeks

plasma levels

A1c

时间窗: 10 weeks

plasma percentage

次要结局

  • 25OHD(10 weeks)
  • Osteocalcin(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Suleiman Abu-Samak

Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics

Applied Science Private University

研究点 (1)

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