CTRI/2023/08/056852尚未招募4 期
Efficacy and safety of vitamin D3 supplementation in the prevention of pre-eclampsia and associated complications: A randomized controlled clinical study
BPS Govt. Medical College Khanpur Kalan, Sonipat1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年1月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pre-eclampsia assessment by blood pressure & proteinuria
研究概览
简要总结
| Pre-eclampsia is a syndrome characterized by pregnancy-induced hypertension and new-onset proteinuria occurring in the second half of pregnancy after 20 weeks of gestation in a previously normotensive woman. It is a multifactorial disorder that carries a high risk to mothers and fetuses worldwide. There is no specific treatment for pre-eclampsia. However, symptomatic treatment of pre-eclampsia primarily involves antihypertensive drugs such as Hydralazine, Labetalol, Nefidipine, Nitroprusside and anticonvulsant magnesium sulfate. Vitamin D deficiency in pregnant women can lead to a high risk of pre-eclampsia, gestational diabetes, preterm labour (<37 weeks), miscarriages, stillbirth, increased rate of caesarean section, low birth weight (≤2500gm), and immaturity. The present study is hypothesized to determine the effect of Cholecalciferol (vitamin D3) supplementation in the prevention of pre-eclampsia and associated complications in pregnant women. Eighty-six pregnant women fulfilling the above criteria will be included in the study. The total duration of the study will be 9 months. Information for this comparative clinical study, which includes, serum vitamin D and serum calcium levels, Liver FunctionTest/Renal Function Test, Plasma glucose levels, Blood Pressure, proteinuria, lipid profile at the beginning, and periodic intervals after adding vitamin D3 supplementation and feto-maternal outcomes at delivery, will be collected by using a predesigned structured proforma. Data will be entered into Microsoft excel sheet, an analytical software will be used for doing statistical analysis. Mean ± S.D. will be calculated for quantitative data. Percentage and proportion will be calculated for categorical data. Student t-test will be used to find out the mean difference between the two groups. Repeated measure ANOVA will be used to find out the mean difference of the prospective time (i.e., follow-up). Post-hoc test, Bonferroni will be used. Chi-square test will be used to find out the association between categorical data using SPSS (version 22) software. A p-value of <0.05 will be considered as statistically significant. |
[1]Summarize in the simplest possible way such that a person with no prior knowledge of the subject can easily understand it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant females who are willing to give written informed consent to participate in the study.
- •Pregnant females of age group 21-35 years with a singleton pregnancy and with a gestation age of 18-19 weeks.
排除标准
- •Pregnant females who are unable or unwilling to give written informed consent.
- •Fetal abnormalities in the current or previous pregnancy
- •History of recurrent miscarriage
- •History of pre-eclampsia
- •History of hypertension
- •Twin pregnancy
- •History of malignancy
- •Known case of osteomalacia
- •Recent history of therapeutic vitamin D3 consumption other than supplementation in the study
- •History of seizures
- •Known case of Diabetes mellitus.
结局指标
主要结局
Pre-eclampsia assessment by blood pressure & proteinuria
时间窗: Baseline 24 weeks, 28 weeks, 32 weeks & 36 weeks of gestation
次要结局
- Serum vitamin D & calcium levels, kidney function tests, liver function tests, lipid profile and cordblood vitamin D levels(Baseline & 36 weeks)
研究者
研究点 (1)
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