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Trial record 78 of 147 for:    severe preeclampsia AND hypertensive disorders

The Correlation Between Vitamin A / E Levels and Preeclampsia

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ClinicalTrials.gov Identifier: NCT03971604
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Preeclampsia Vitamin A Deficiency Vitamin E Deficiency Drug: Vitamin A Drug: Vitamin E Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Official Title: The Correlation Between Vitamin A / E Levels and Preeclampsia.
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022


Arm Intervention/treatment
Experimental: group 1
treated with VA
Drug: Vitamin A
treated with Vitamin A

Experimental: group 2
treated with VE
Drug: Vitamin E
treated with Vitamin E

Experimental: group 3
treated with VA+VE
Drug: Vitamin A
treated with Vitamin A

Drug: Vitamin E
treated with Vitamin E

No Intervention: group 4
No intervention



Primary Outcome Measures :
  1. 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 serum VA and VE levels between normal pregnant women and pre-eclampsia pregnant women

  2. 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 compare the levels of VA and VE in pregnant women with mild and severe preeclampsia

  3. 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 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

  4. 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 ]
    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.) .



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-45 years of natural pregnancy, early pregnancy without threatened abortion and infection
  2. No history of hypertension, diabetes, heart disease and other internal and surgical diseases
  3. Pregnancy are normal to take folic acid and calcium tablets, did not take other drugs
  4. Agree to participate in the experiment and sign the informed consent

Exclusion Criteria:

  1. Refuse to sign or request to withdraw the informed consent midway
  2. Serious adverse events, allergies or intolerance
  3. Poor patient compliance, refused to cooperate with the experimental requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971604


Contacts
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Contact: liquan wang 15868448702 wangliquan@zju.edu.cn
Contact: jing chen 19817152003 775917243@qq.com

Locations
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China, Zhejiang
The second affiliated hospital of medical college of zhejiang university Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: liquan wang, doctor    15868448702    wangliquan@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Director: liquan wang 2th affiliated hospital of medical college of zhejiang university

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03971604     History of Changes
Other Study ID Numbers: W2016CWZJ07
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Deficiency Diseases
Nutrition Disorders
Vision Disorders
Eye Diseases
Night Blindness
Vitamin A Deficiency
Vitamin E Deficiency
Pregnancy Complications
Avitaminosis
Malnutrition
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents