Role of L-citrulline in Prevention of Pregnancy Associated Hypertension
Study Details
Study Description
Brief Summary
The target population for our study is healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy.
If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily L-citrulline supplementation or placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy will be eligible for this study. The purpose of this study will be to determine if daily supplementation of oral L-citrulline can reduce the incidence of pregnancy induced hypertension. This will be a double blind study, subjects will be randomized to receive either L-citrulline (3 gram sachet) or a placebo for a total of 8 weeks. Participants will be asked to provide urine and blood samples at time of enrollment, be asked to respond to a phone survey to assess for side effects, and again be asked to provide urine and blood samples at the end of 8 weeks. Participants will continue with routine prenatal care throughout the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Placebo Oral placebo, 3 grams milk powder sachet, taken once daily |
Drug: Placebo
Milk powder placebo
|
| Experimental: Daily L-citrulline L-citrulline, 3 grams L-citrulline sachet, taken once daily |
Drug: L-citrulline
3 gram sachet, L-citrulline
|
Outcome Measures
Primary Outcome Measures
- Incidence of pregnancy induced hypertension [To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.]
Incidence of pregnancy induced hypertension conditions (gestational hypertension, preeclampsia, or eclampsia) between treatment and placebo groups will be assessed by chart review after end of pregnancy
Secondary Outcome Measures
- Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration [Baseline at start of study and again after 8 weeks treatment]
Assessment of change in serum L-citrulline and asymmetric dimethyl arginine (ADMA ) levels with L-citrulline administration between treatment and placebo groups. Serum samples will be collected at the beginning of study and after 8 weeks and assayed for ADMA and L-citrulline
- Change in maternal nitric oxide levels with L-citrulline supplementation [Baseline at start of study and again after 8 weeks treatment]
Assessment of change in nitric oxide levels between treatment and placebo groups by measurement of baseline and 8 week post treatment urine nitrate and nitrite concentrations
- Maternal blood pressure [Baseline at start of study, and approximately every 1-4 weeks after randomization at prenatal appointments throughout pregnancy. Also at time of delivery approximately 8-9 months after randomization..]
Assessment of maternal blood pressure throughout study
- Maternal Morbidity [To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.]
Composite assessment of incidence of maternal outcomes to include development of preeclampsia; Hemolysis, Elevated liver enzymes, Low Platelets (HELLP) syndrome; eclampsia; indicated preterm birth less than 32 weeks due to hypertension related disorders
- Birth weight [To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.]
To assess the actual birthweight of neonate by chart review at time of delivery. This outcome is different than fetal growth restriction noted in outcome 5.
- Neonatal Outcomes [To be assessed by chart review 8-9 months after enrollment at time of delivery]
To determine the incidence of neonatal outcomes by chart review after delivery that include respiratory distress syndrome, necrotising enterocolitis, bronchopulmonary dysplasia (BPD), and BPD related pulmonary hypertension, retinopathy of prematurity, age at full feed, and length of hospital stay, fetal growth restriction defined as less than 10% of predicted gestational age, fetal death after 20 weeks gestation, and neonatal death
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Nulliparous (no previous pregnancy greater than 20 weeks)
-
Gestational age of pregnancy between 12 and 16 weeks
Exclusion Criteria:
-
Known fetal anomaly or chromosomal abnormality
-
Early fetal growth restriction
-
Fetal demise or planned termination
-
Participation in another study that may influence this study
-
Known maternal kidney disease
-
Known maternal electrolyte imbalance
-
Known allergies to study interventions
-
Preexisting hypertension (chronic hypertension)
-
Known gastric ulcer
-
Incarcerated status
-
Planned delivery at non-UTMB hospital
-
Known lactose intolerance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0156 |
Sponsors and Collaborators
- The University of Texas Medical Branch, Galveston
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-0167