Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in clinic blood pressure (compared to baseline) between treatment and placebo groups
研究概览
简要总结
High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with serious adverse outcomes for both mother and baby. Treatment options for the management of high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals have shown that supplementation with dietary nitrate, using beetroot juice, can significantly lower blood pressure and improve blood flow. This study aims to investigate whether supplementation with dietary nitrate (via beetroot juice) can improve blood pressure regulation in pregnant women with chronic high blood pressure, and will also determine whether this can improve blood flow across the placenta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with chronic hypertension (systolic blood pressure of 130-144 mmHg and/or diastolic blood pressure of 80-94 mmHg).
- •Between 22 - 35+6 weeks gestation
排除标准
- •Multi-fetal pregnancy
- •Currently taking anti-hypertensive medication
- •Pre-existing diabetes (Type 1 or Type 2)
- •Lacking ability to consent
研究组 & 干预措施
Dietary nitrate, beetroot juice
Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days.
干预措施: Beetroot juice (Dietary Supplement)
Nitrate-depleted beetroot juice
Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days.
干预措施: Nitrate-depleted beetroot juice (Dietary Supplement)
结局指标
主要结局
Change in clinic blood pressure (compared to baseline) between treatment and placebo groups
时间窗: The outcome will be determined after 7 days treatment (compared to baseline)
次要结局
- Recruitment rates(Across study (18 months))
- Uterine artery blood flow (compared to baseline)(The outcome will be determined after 7 days treatment (compared to baseline))
- Umbilical artery blood flow (compared to baseline)(The outcome will be determined after 7 days treatment (compared to baseline))
- Changes in plasma and salivary nitrate concentrations(The outcome will be determined after 7 days treatment (compared to baseline))
- Changes in plasma and salivary nitrite concentrations(The outcome will be determined after 7 days treatment (compared to baseline))
研究者
Dr Jenny Myers
Dr
Manchester University NHS Foundation Trust