Effects of Dietary Nitrate in Hypertensive Pregnant Women

University of Manchester

Status: Completed

Conditions: Hypertension; Pregnancy

Treatments: Dietary Supplement: Beetroot juice; Dietary Supplement: Nitrate-depleted beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT02520687

15136

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Multi-fetal pregnancy
• Currently taking anti-hypertensive medication
• Pre-existing diabetes (Type 1 or Type 2)
• Lacking ability to consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups, including a placebo group

Dietary nitrate, beetroot juice

Experimental group

Description:

Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days.

Treatment:

Dietary Supplement: Beetroot juice

Nitrate-depleted beetroot juice

Placebo Comparator group

Description:

Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days.

Treatment:

Dietary Supplement: Nitrate-depleted beetroot juice