An interventional study of Vitamin A and Vitamin E in Preeclampsia, Vitamin A Deficiency and Vitamin E Deficiency, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-03.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Prevention
Among 36 studies in Pre-Eclampsia with a site in China — 12 open to participants now, 13 under way, 2 of them phase 3. Pre-Eclampsia · China.
Among the 36 studies in Pre-Eclampsia with a site in China, this one is the 9th largest by planned enrollment of the 19 interventional ones that give a count, is one of 4 that started in 2019, is one of 12 with no phase, and was the 10th registered.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
Browse Pre-Eclampsia studies →12 of the 36 studies in Pre-Eclampsia with a site in China are open now. Recruiting first, the newest first:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Sites in China
Ages 22–40 · Women only
FANG HE · Sites in China
Ages 18–45 · Women only
Peking University Third Hospital · Sites in China
Ages 18–45 · Women only · Healthy volunteers
General Hospital of Ningxia Medical University · Sites in China
Ages 18–45 · Women only
FANG HE · Sites in China
Ages 18–45 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years to 45 Years · female · healthy volunteers too.
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36 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 4 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Median enrollment 180 across the 19 interventional studies, 1,000 across the 17 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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3 of 36 have an industry lead sponsor. The 10 most frequent:
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Second Affiliated Hospital, School of Medicine, Zhejiang University has 1 study filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
3 of the studies in Pre-Eclampsia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06414655Peking University Third HospitalMulticenter Prospective Cohort Study of Twin Maternal-Child Dyads in China | 2026-11-30 |
| NCT07384936Fang WangTopefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia | 2027-05 |
| NCT06821685The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolAutologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History | 2027-07 |
Add all 3 to your calendar (.ics) → With an account.
Among the 36 studies in Pre-Eclampsia with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Vitamin A (VA) and vitamin E (VE) are fat-soluble vitamins and indispensable substances in life activities.
VA plays an important role in visual function, normal formation and development of epithelial cells, development and growth of bones, immune function and reproductive health. VA is of great significancCe for the growth and development of embryonic cells, especially for the development of fetal vertebrae, spinal cord, limbs, heart, eyes and ears. The lack of maternal VA will lead to the stunted development of fetal organs and tissues, and even fetal developmental malformation. In addition, VA has a protective effect on neonatal lung maturation.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 and improve vascular endothelial function. Long-term administration of VE can improve the impaired endothelium-dependent vasodilatory function in patients.VE can promote sex hormone secretion, improve fertility and prevent 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, cause the placenta aging, vascular endothelial damage, increase the risk of the occurrence of PHI and adverse outcome rate, as well as the membranes of cell membrane damage, increase the risk of premature rupture of membranes.
Gestational hypertension is a group of diseases with both pregnancy and elevated blood pressure, and is the main cause of increased maternal and perinatal mortality, mainly including gestational hypertension, preeclampsia PE, and eclampsia, as well as chronic hypertension with preeclampsia and chronic hypertension with pregnancy. 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, local immune cell activity, make produce free radicals increases, interfere with the vascular endothelial cell function, reduce vascular relaxation material synthesis, and shrink blood vessels increase material synthesis, 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 are increased in PHI patients, while the levels of VA and VE are closely related to the antioxidant capacity of the body, and their lack can lead to the imbalance of the homeostasis of redox reaction in multi-tissue cells in the body. Since both VA and VE belong to fat-soluble vitamins and are widely distributed in daily food, whether their effects on the occurrence and development of PE are independent or combined will be a question for us to explore. Therefore, this study intends to evaluate the correlation between VA, VE and VA+VE and PE occurrence through multi-center clinical studies, and explore and summarize the feasibility of VA and VE in PE adjuvant treatment.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treated with VA
Drug: Vitamin A
treated with VE
Drug: Vitamin E
treated with VA+VE
Drug: Vitamin A · Drug: Vitamin E
No intervention
To compare the serum VA and VE levels between normal pregnant women and pre-eclampsia pregnant women
To compare the serum VA and VE levels between normal pregnant women and pre-eclampsia pregnant women
Time frame: change from 20 to 37 weeks
To compare the levels of VA and VE in pregnant women with mild and severe preeclampsia
To compare the levels of VA and VE in pregnant women with mild and severe preeclampsia
Time frame: change from 20 to 37 weeks
To analyze the changes in serum levels of VA and VE in pregnant women with mild and severe preeclampsia, as well as the effects of independent and combined intake of VA and VE on the disease
To analyze the changes in serum levels of VA and VE in pregnant women with mild and severe preeclampsia, as well as the effects of independent and combined intake of VA and VE on the disease
Time frame: change from 20 to 37 weeks
To analyze the correlation between serum VA and VE levels in the case group and important indicators related to the disease (such as blood pressure, body weight, hematuria routine, liver and kidney function, etc.) .
To analyze the correlation between serum VA and VE levels in the case group and important indicators related to the disease (such as blood pressure, body weight, hematuria routine, liver and kidney function, etc.) .
Time frame: change from 20 to 37 weeks
Started Jan 2019 (actual). Primary completion is estimated for Jan 2022, 36 months after the start.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 36 months is above that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vitamin A · Vitamin E
Second Affiliated Hospital, School of Medicine, Zhejiang University →