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PreeclampsiaNCT03971604

The Correlation Between Vitamin A / E Levels and Preeclampsia

A study testing Vitamin A and Vitamin E in people with Preeclampsia and Vitamin A Deficiency, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Vitamin A and Vitamin E
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
1 Jan 2019to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • The second affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang, 310000

    liquan wang, doctor, 15868448702, wangliquan@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Correlation Between Vitamin A / E Levels and Preeclampsia.

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.

Read more

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.

Read the detailed 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 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.

Being tested
Vitamin A, Vitamin E
Medical subject headings
Pre-Eclampsia, Vitamin A Deficiency, Vitamin E Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin ADrug

    treated with Vitamin A

  • Vitamin EDrug

    treated with Vitamin E

Study groups in NCT03971604
Study groupRoleWhat they receive
group 1Experimentaltreated with VA
Receives: Drug: Vitamin A
group 2Experimentaltreated with VE
Receives: Drug: Vitamin E
group 3Experimentaltreated with VA+VE
Receives: Drug: Vitamin A; Drug: Vitamin E
group 4No interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: change from 20 to 37 weeks

  2. 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

    Measured: change from 20 to 37 weeks

  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

    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

    Measured: change from 20 to 37 weeks

  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.) .

    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.) .

    Measured: change from 20 to 37 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03971604
Sponsor's protocol ID
W2016CWZJ07
Status last verified
May 2019
First submitted
14 May 2019
Last updated
3 Jun 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin A and Vitamin E in people with Preeclampsia and Vitamin A Deficiency, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact liquan wang (15868448702, wangliquan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.

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