CAREFOL-HT
Research type
Research Study
Full title
CAREFOL-HT, Clinical Antenatal Randomised study to CharactErise key roles of TetrahydroFOLate in HyperTensive Pregnancies
IRAS ID
295830
Contact name
Paul Leeson
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Previous research has shown certain biological processes may be disturbed in women with high blood pressure in pregnancy. One of these processes involves a molecule called tetrahydrobiopterin (BH4) which is required for the correct functioning of blood vessels. We have seen lower levels of BH4 in both the placenta and the umbilical cord from mothers with high blood pressure as well as lower levels of BH4 in pregnant mice affected by high blood pressure. In both mice and human umbilical vein cells, increasing the level of BH4 using a nutritional supplement 5-methyltetrahydrofolate (5-MTHF), reversed the effects of the condition. The purpose of this study is to find out if circulating BH4, plays a role in humans affected by preeclampsia and if its blood levels are associated with changes in the structure and function of the heart and blood vessels in both mother and baby. We plan to investigate the levels of BH4 by performing a single site, double blinded randomised controlled trial. Women with severe preeclampsia will be recruited and levels of BH4 will be changed by oral supplementation of either 5-MTHF(low dose or high dose) or placebo. A group of women without blood pressure complications in pregnancy will also be recruited to provide validation to the study measurements. In all women, we will measure blood levels of BH4 and other molecules involved in the pathway of blood vessel function at two time points, prior to supplementation and just before delivery. We will also measure heart and blood vessel function in both mother and baby. After delivery, we will collect the umbilical cord and placental tissue to assess blood vessel cell function in the baby and the impact of changing levels of BH4 in the mother.
REC name
Wales REC 6
REC reference
21/WA/0169
Date of REC Opinion
17 Jun 2021
REC opinion
Further Information Favourable Opinion