Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Preeclampsia
  • Vitamin A Deficiency
  • Vitamin E Deficiency
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Group 1: Treated with VA, Group 2: Treated with VE, Group 3: Treated with VA+VE. To evaluate and compare the blood pressure, weight, uterine height, abdominal circumference, fetal b-mode ultrasound, blood results (blood routine, including blood VA/VE level), methods of termination of pregnancy, obstetric complications and neonatal conditions (including body length, weight, Apgar score, umbilical cord blood VA, VE level, etc.) among the three groups.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Description

Vitamin A (VA) and vitamin E (VE) are fat-soluble vitamins, which participate in the metabolism of important substances in the body and are indispensable substances in life activities. VA, also known as retinol, plays an important role in visual function, normal formation and development of epitheli...

Vitamin A (VA) and vitamin E (VE) are fat-soluble vitamins, which participate in the metabolism of important substances in the body and are indispensable substances in life activities. VA, also known as retinol, plays an important role in visual function, normal formation and development of epithelial cells, development and growth of bones, immune function and reproductive health. During fetal development, VA affects cell differentiation and proliferation by regulating gene expression, which is of great significance for the growth and development of embryonic cells, especially for the development of fetal vertebrae, spinal cord, limbs, heart, eyes and ears. Maternal lack of VA will lead to the fetal,s organ tissue dysplasia, even serious fetal development deformity. In addition, VA can promote the growth of columnar epithelial cells on the surface of alveoli, and has a certain protective effect on the maturation of neonatal lungs. VA deficiency can cause the decrease in the activity of enzymes needed to catalyze the formation of progesterone precursors in pregnant women, reduce the production of steroids in adrenal glands, gonads and placenta, and seriously affect the functions of multiple organs such as heart, liver and skeletal muscle in pregnant women. VE, also known as tocopherol, has non-enzymatic antioxidant function, and maintains the balance of REDOX reaction in vivo by efficiently removing free radicals generated by lipid peroxidation.VE can increase the synthesis of nitric oxide (NO) in endothelial cells, release electrons to stabilize free radicals, protect NO from inactivation of free radicals, and improve vascular endothelial function. Long-term use of VE has been found to improve endothelium-dependent vasodilation in patients with impaired vasodilation.VE can promote sex hormone secretion, improve fertility, prevent abortion, clinically commonly used VE treatment threatened abortion and habitual abortion. Pregnancy women the body's metabolism, increases produce free radicals, lipid peroxidation, low levels of VE will result in the accumulation of excess free radicals, which cause the placenta aging, vascular endothelial damage, increase the risk of the occurrence of PIH and adverse outcome rate, and cell membrane damage of membranes, the occurrence of premature rupture of membranes increased risk. Gestational hypertension disease is a group of disease and high blood pressure, pregnancy rate is about 5% - 12%, serious impact on maternal and child health, is a major cause of maternal and perinatal mortality increase, mainly including gestational hypertension, preeclampsia preeclampsia (PE), eclampsia, and chronic hypertension complicated by preeclampsia and chronic hypertension with pregnancy. Preeclampsia is the most common type, including mild and severe preeclampsia, of which severe preeclampsia accounts for about 30% to 50%.The cause of PE is unknown, but studies have found that it may be related to insufficient recast of spiral uterine arterioles, excessive activation of inflammatory immune system, damage of vascular endothelial cells, genetic factors, nutritional deficiency and insulin resistance. Recent studies have found that free radical oxidative damage may also be one of the main reasons for the occurrence and development of PE.PE occurs, the placenta bed vasospasm, ischemia, angiogenesis blocking and endothelial atherosclerotic changes, strengthen local immune cell activity, increase the free, free radical and lipid peroxide interfere with the vascular endothelial cell function, make blood-vessel loose material such as nitric oxide (NO), top ring element synthesis reduce I2, materials and shrink blood vessels, such as endothelin (ET), thromboxane A2, such as synthetic increase, promote vascular spasm, platelet condensed state is changed, thus appeared a series of PE. Previous studies have shown that oxygen free radicals and lipid peroxides increase in the body of patients with PIH, and excessive antioxidants are consumed. However, the levels of VA and VE are closely related to the antioxidant capacity of the body, and the lack of them can lead to the imbalance of redox reaction homeostasis in multi-tissue cells in the body, thus resulting in the occurrence of oxidative stress in the body. Studies have found that oxidative stress can cause the occurrence and development of PE when the levels of VA and VE are reduced. Therefore, it is not clear whether the application of VA and VE can reduce the incidence of PE and improve the prognosis of neonates. Since both VA and VE belong to the family of fat-soluble vitamins and are widely present in daily food, are they independent or combined in influencing the occurrence and development of PE. Therefore, this study intends to evaluate the correlation between VA, VE and VA+VE in PE during pregnancy through multi-center clinical studies, and explore and summarize the feasibility of VA and VE in PE adjuvant treatment.

Tracking Information

NCT #
NCT03971604
Collaborators
Not Provided
Investigators
Study Director: liquan wang 2th affiliated hospital of medical college of zhejiang university