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临床试验/NCT03701087
NCT03701087Unknown早期 1 期

Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2018年8月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
430
试验地点
1
主要终点
incidence of gestational diabetes recurrence

研究概览

简要总结

primary outcome is vitamin D intake in first trimester for pregnant women with history of gestational diabetes in previous pregnancies and incidence of gestational diabetes recurrence secondary outcome is effect of vitamin D intake on mode of delivery, apgar score and neonatal birth weight

详细描述

it is a prospective randomized controlled study to determined the effect of vitamin D supplementation in pregnancy in reducing the incidence of gestational diabetes recurrence. it will be conducted at the department of obstetrics and gynecology kasr el ainy hospital faculty of medicine Cairo university from August 2018 to April 2020. we include in our study 430 pregnant women who had history of gestational diabetes in their previous pregnancies. patients with multiple pregnancy or with any medical disorder are excluded from study. BMI will be calculated for each participant at the time of admission and glucose challenge test will be performed for all patients in the first trimester to exclude diabetic patients from the study then a blood sample is taken from all patients enrolled in the study to measure the vitamin D level by ELISA (after fasting 12 hours and not have a fatty dinner) the participants will be assigned to one of three main groups according to the serum 25 OH vitamin D level. pregnant women with normal vitamin D level assigned as group A, pregnant women with lower serum level of vitamin D (>20 nmol/L) randomly divided into two groups: group B and C. Group B will be given oral vitamin D 2800 units daily till 26 week pregnancy and group C will be given Omega 3 as placebo till 26 week pregnancy. incidence of gestational diabetes will be measured in 24-26 week pregnancy with OGTT and compared in the three groups. All patients will be followed up till delivery. Mode of delivery, Apgar score and neonatal birth weight will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women with history of gestational diabetes in previous pregnancies

排除标准

  • multiple pregnancy
  • pregnant patient with medical disorders

研究组 & 干预措施

low serum level of vitamin D

Experimental

this arm will intake vitamin D 2800 IU daily

干预措施: Vitamin D (Drug)

low serum vitamin D

Placebo Comparator

this arm will intake placebo omega 3

干预措施: Vitamin D (Drug)

结局指标

主要结局

incidence of gestational diabetes recurrence

时间窗: 2 years

incidence of gestational diabetes recurrence

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hadeer meshal

assistant professor

Kasr El Aini Hospital

研究点 (1)

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