Development of a new treatment for Preeclampsia using nicotinamide (a water-soluble vitamin)

2022 Fiscal Year Final Research Report

• Project/Area Number: 19K18687
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 56040:Obstetrics and gynecology-related
• Research Institution: Tohoku University
• Principal Investigator: Tadakawa Mari 東北大学, 大学病院, 助教 (10836547)
• Project Period (FY): 2019-04-01 – 2023-03-31
• Keywords: 妊娠高血圧腎症 / 妊娠高血圧症候群 / ニコチンアミド

Outline of Final Research Achievements

The purpose of this study is to evaluate the safety and efficacy of nicotinamide in patients with PE in a clinical trial and to analyze the drug's mechanism of action by high-precision metabolomic analysis of maternal blood and urine. The endpoints of this clinical trial are prolonged gestation period and improved prognosis for mother and child. The efficacy endpoints include decreased proteinuria, increased fetal growth, and decreased maternal and infant complications. The results of this exploratory study were used to determine the primary and secondary endpoints for future Phase I-III studies.
Although one patient was enrolled in this study based on collaboration with the Tohoku University Center for the Promotion of Clinical Research, the initial study objective could not be reached due to the spread of novel coronavirus infection.

Free Research Field

周産期医学

Academic Significance and Societal Importance of the Research Achievements

妊娠高血圧腎症は、全妊娠の2-8％に合併する原因不明の疾患であり、低出生体重児、脳性麻痺、子宮内胎児死亡など母児の重篤な合併症の主要因として重要である。
本研究では、ニコチンアミドのPE 患者での安全性・有効性を探索的臨床試験にて評価し、母体血液・尿の高精度メタボローム解析にて薬効機序を解析することを目的とした。投与予定患者数は６名であったが、新型コロナウィルス感染症まん延により、1名の登録にとどまった。今後、エンドポイントを妊娠期間延長・母児の予後改善とし、有効性の評価項目として、蛋白尿の減少・胎児発育の増加・母児合併症の減少とする第I-III相試験をデザインする必要がある。