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Dietary Salicylates and Preeclampsia

Nutritional Sources of Salicylates and Disorders of Placental Angiogenesis in Preeclampsia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06239363
Acronym
PreSal
Enrollment
500
Registered
2024-02-02
Start date
2024-01-08
Completion date
2028-09-30
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Habit, Preeclampsia, Pregnancy Disease

Keywords

pregnancy, preeclampsia, angiogenesis, salicylates

Brief summary

Preeclampsia (PE) is an important pregnancy complication and cause of maternal and perinatal mortality and morbidity. The underlying etiology and pathophysiology of preeclampsia is incompletely understood but it involves dysfunctional cytotrophoblastic invasion, placental ischemia, and release of inflammatory and endothelial mediators. Placenta dysfunction in PE is related to angiogenic balance. Currently, therapeutic options for the prevention and treatment of PE are limited. It is known that the risk of PE is reduced by low-dose aspirin. Therefore, the influence of salicylates on the development of PE seems to need to be investigated. This project plans to examine the preventive effects of food sources of salicylic acid and compare their effects with aspirin. Therefore, the aim of the present study is thus answer the following questions. whether the maternal dietary intake of salicylates is related to placental angiogenesis; 2. whether naturally occurring salicylates have the same effects on preeclampsia development and placental angiogenesis as aspirin. To answer these questions we plan to carry out a human study with pregnant women. Due to the above the planned research aims to determine the association between maternal dietary intake of salicylates and placental angiogenesis and the risk of preeclampsia development. Although PE remains an incurable disease, the results of this project will enable the development of dietary recommendations for the prevention and treatment of preeclampsia. Moreover, the results of this study may be useful in lowering the cost of maternal and fetal complications from preeclampsia and the cost of their hospitalization.

Detailed description

Preeclampsia (PE) is one of the most important complications in pregnancy worldwide and is responsible for over 70,000 maternal deaths each year around the world. Babies born to women with PE often suffer from intrauterine growth restriction and preterm birth along with increased fetal pro-inflammatory profiles which require a long and costly hospitalization. PE results in placental dysfunction and it is now accepted that PE is a placental disease. Placenta dysfunction in PE is related to impaired angiogenic balance. Currently, therapeutic options for the prevention and treatment of PE are limited. It is known that the risk of PE is reduced by low-dose aspirin. Therefore, the influence of salicylates on the development of PE seems to need to be investigated. This project plans to examine the preventive effect of natural salicylates and compare their effects with aspirin. Therefore, the aim of the present study thus answer the following questions. whether the maternal dietary intake of natural salicylates is related to placental angiogenesis; 2. whether naturally occurring salicylates have the same effects on preeclampsia development and placental angiogenesis as aspirin. The study will aim to determine the association between maternal dietary intake of salicylates and placental angiogenesis and the risk of preeclampsia development. The study will be carried out in around 500 pregnant women (healthy and with PE) aged 18-45 years. Daily food intake will be determined based on the FFQ questionnaire and dietary intake interviews. The amount of salicylic acid and total salicylates in the daily diet will be processed and evaluated. Blood samples were collected from a maternal vein at the time of delivery. In plasma, it will be assayed salicylates, salicylic acid, TNFα, and hsCRP concentrations. Biomarkers of angiogenesis will be assayed in plasma: concentration of VEGF, PLGF, and sFLT1. The placentas will be collected after delivery. Biomarkers of angiogenesis will be assayed in the placenta: concentration of VEGF, PLGF, and sFLT1. In the placenta, it will be measured mRNA and proteins of STOX 1. The vascularization process will be evaluated in the placenta. Women will collect 24-hour urine. Salicylates and salicylic acid will be assayed in urine.

Interventions

None listed

Sponsors

Poznan University of Life Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* age 18-45 years * healthy women with no previous adverse medical history and women with diagnosed preeclampsia * singleton pregnancy * people who have the full ability to give informed consent.

Exclusion criteria

* pregnancies with detectable fetal defects, chromosomal abnormalities, genetic syndromes * infections * history of chronic hypertension, metabolic disorder before or during pregnancy, or the presence of high-risk factors such as heart diseases, diabetes, and renal diseases.

Design outcomes

Primary

MeasureTime frameDescription
daily intake using 24-hour Dietary Recall3 yearsevaluation of daily intake of nutrients (carbohydrate, fat, protein, vitamins, minerals, energy)
salicylates3 yearsmeasure in plasma and urine
angiogenesis biomarker: sFLT13 yearsmeasure in plasma and placenta
angiogenesis biomarker: VEGF3 yearsmeasure in plasma and placenta
angiogenesis biomarker: PLGF3 yearsmeasure in plasma and placenta
STOX-1 protein3 yearsmeasure in placenta
inflammatory biomarker: TNFα3 yearsmeasure in plasma
inflammatory biomarker: hsCRP3 yearsmeasure in plasma

Countries

Poland

Contacts

CONTACTJoanna Suliburska, Professor
joanna.suliburska@up.poznan.pl+48 61 8487260

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026