The Correlation Between Vitamin A / E Levels and Preeclampsia

NCT03971604 | Unknown

• 1 other identifier: W2016CWZJ07
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Vitamin A Deficiency; Vitamin E Deficiency

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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.) .

  change from 20 to 37 weeks

Study Arms (4)

group 1

EXPERIMENTAL

treated with VA

Drug: Vitamin A

group 2

EXPERIMENTAL

treated with VE

Drug: Vitamin E

group 3

EXPERIMENTAL

treated with VA+VE

Drug: Vitamin A; Drug: Vitamin E

group 4

NO INTERVENTION

No intervention

Interventions

Vitamin A DRUG

treated with Vitamin A

group 1; group 3

Vitamin E DRUG

treated with Vitamin E

group 2; group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Vitamin A Deficiency; Vitamin E Deficiency

Interventions

Vitamin A; Vitamin E

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• liquan wang

  2th affiliated hospital of medical college of zhejiang university

  STUDY DIRECTOR

Central Study Contacts

liquan wang

CONTACT

15868448702; wangliquan@zju.edu.cn

jing chen

CONTACT

19817152003; 775917243@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: June 3, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: June 3, 2019

Record last verified: 2019-05

Locations

CN (1)