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临床试验/NCT03735303
NCT03735303已完成不适用

The Combined Effect of Vitamin D3 and Omega-3 Supplements on Serum Leptin and Glycated Hemoglobin (Hb A1C) Levels in Jordanian People With Vitamin D Deficiency.

Applied Science Private University2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
2
主要终点
HbA1C

研究概览

简要总结

The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

详细描述

Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • jordanian people aged 25-55
  • medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)

排除标准

  • Blood disorders including
  • thalassemia
  • sickle cell disease

研究组 & 干预措施

VD3 group

Experimental

dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks

干预措施: VD3 group (Dietary Supplement)

omega 3- FA group

Experimental

dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks

干预措施: omega 3 FA group (Dietary Supplement)

VD3 and omega 3 FA group

Experimental

dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks

干预措施: VD3 and omega- 3FA group (Dietary Supplement)

control group

Experimental

no intervention was given

干预措施: control group (Other)

结局指标

主要结局

HbA1C

时间窗: 8 weeks

plasma concentration of HbA1C

leptin

时间窗: 8 weeks

serum level of leptin

VD 3

时间窗: 8 weeks

Serum level of 25-hydroxyvitamin D

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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