NCT03971604

The Correlation Between Vitamin A / E Levels and Preeclampsia

Status unknown NA Last updated 3 June 2019

What this trial tests

NA trial testing Vitamin A in Preeclampsia in 300 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	300
Start date	1 January 2019
Primary completion	1 January 2022
Estimated completion	1 January 2022
Sites	1 location across China

Drugs / interventions tested

• Vitamin A — full drug profile →
• Vitamin E (VITAMIN E) — full drug profile →

Conditions studied

• Preeclampsia — all drugs for Preeclampsia →
• Vitamin A Deficiency — all drugs for Vitamin A Deficiency →
• Vitamin E Deficiency — all drugs for Vitamin E Deficiency →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 45, female only, with Preeclampsia or Vitamin A Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.