Chronic Hypertension and l-citrulline study

Phase 2

Completed

• Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; Reproductive Health and Childbirth; UKCRC code/ Disease: Reproductive Health and Childbirth/ Respiratory and cardiovascular disorders specific to the perinatal period; Pregnancy and Childbirth

• Registration Number: ISRCTN12695929
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37789125/ (added 04/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-20
• Study Completion: 2019-01-04
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

1. Viable singleton pregnancy
2. Gestation: 12+0 to 16+0 weeks
3. Aged 18 years or over
4. Able to provide informed consent
5. Diastolic BP of =90 mmHg (average of two clinic readings) OR =80 mmHg if taking antihypertensive medication OR PWV =9m/s before 16 weeks’ gestation
6. Serum creatinine <120 mmol/l at booking

Exclusion Criteria

There is no exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment rate is measured by number of women recruited and completing study per month<br>2. Change in diastolic blood pressure (from baseline to 8 weeks post randomisation following L- citrulline supplementation, compared with placebo – Change in clinic diastolic BP (average of 3 readings) will be calculated at baseline and week 8