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Effects of Dietary Nitrate in Hypertensive Pregnant Women

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ClinicalTrials.gov Identifier: NCT02520687
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Jenny Myers, Manchester University NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Pregnancy Dietary Supplement: Beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women
Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dietary nitrate, beetroot juice
Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days.
Dietary Supplement: Beetroot juice
200mls daily for seven days

Placebo Comparator: Nitrate-depleted beetroot juice
Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days.
Dietary Supplement: Nitrate-depleted beetroot juice
200mls daily for seven days




Primary Outcome Measures :
  1. Change in clinic blood pressure (compared to baseline) between treatment and placebo groups [ Time Frame: The outcome will be determined after 7 days treatment (compared to baseline) ]

Secondary Outcome Measures :
  1. Recruitment rates [ Time Frame: Across study (18 months) ]
  2. Uterine artery blood flow (compared to baseline) [ Time Frame: The outcome will be determined after 7 days treatment (compared to baseline) ]
  3. Umbilical artery blood flow (compared to baseline) [ Time Frame: The outcome will be determined after 7 days treatment (compared to baseline) ]
  4. Changes in plasma and salivary nitrate concentrations [ Time Frame: The outcome will be determined after 7 days treatment (compared to baseline) ]
  5. Changes in plasma and salivary nitrite concentrations [ Time Frame: The outcome will be determined after 7 days treatment (compared to baseline) ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520687


Locations
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United Kingdom
Maternal and Fetal Health Research Centre
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
University of Manchester

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Responsible Party: Dr Jenny Myers, Dr, Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02520687     History of Changes
Other Study ID Numbers: 15136
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases