Nutraceutical Citrulline in Pregnancy
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|ClinicalTrials.gov Identifier: NCT02772887|
Recruitment Status : Terminated (Inability to successfully recruit study participants)
First Posted : May 16, 2016
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Dietary Supplement: L-Citrulline Other: Placebo||Not Applicable|
The pregnancy-specific syndrome preeclampsia is a leading cause of maternal and fetal morbidity and mortality. The underlying cause of preeclampsia is unknown, however several pre-existing maternal conditions are associated with an increased risk of preeclampsia including: diabetes, hypertension, renal dysfunction, obesity and history of preeclampsia. Specifically, the risk of preeclampsia is five times greater in women with diabetes.
Several lines of evidence indicate that endothelial dysfunction is a central feature of the pathophysiology of preeclampsia. Asymmetric dimethylarginine (ADMA) is a methylated metabolite of the amino acid L-arginine and an endogenous inhibitor of nitric oxide synthase (NOS). High concentrations of ADMA contribute to endothelial dysfunction and ADMA inhibits angiogenesis and arteriogenesis, activities important in pregnancy and deficient in preeclampsia. ADMA concentrations are higher early in pregnancy among women who later develop preeclampsia. This protocol describes a randomized placebo-controlled trial of L-citrulline in 40 pregnant women with type 2 diabetes from approximately sixteen to nineteen weeks gestation, to determine whether L-citrulline supplementation increases the plasma L-arginine/ADMA ratio, lowers maternal blood pressure and increases a circulating marker of placental function (placental growth factor PLGF).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Phase 1 Trial Citrulline and Type 2 Diabetes in Pregnancy|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Oral L-citrulline, 3 grams once per day for 3 weeks.
Dietary Supplement: L-Citrulline
amino acid supplement
Placebo Comparator: Placebo
Placebo, 3 grams once per day for 3 weeks.
- Blood pressure [ Time Frame: approximately 20 weeks ]research measure
- Placental growth factor (PlGF) [ Time Frame: approximately 20 weeks ]quantified by ELISA
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): NCT02772887
|United States, Pennsylvania|
|Magee-Womens Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|