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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
Sponsor:
Information provided by (Responsible Party):
Robert Powers, University of Pittsburgh

Brief Summary:
The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma L-arginine/ADMA ratio, lower maternal blood pressure and increase maternal levels of placental growth factor (PlGF).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: L-Citrulline Other: Placebo Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Citrulline
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.
Other: Placebo
placebo




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: approximately 20 weeks ]
    research measure


Secondary Outcome Measures :
  1. Placental growth factor (PlGF) [ Time Frame: approximately 20 weeks ]
    quantified by ELISA



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Type 2 diabetes with hemoglobin A1c <8
  • Gestational age at randomization between 14 and 16 weeks based on clinical information
  • Maternal age between 14 and 40 years

Exclusion Criteria:

  • Chronic hypertension
  • Major fetal anomaly
  • Fetal demise
  • Planned termination of the pregnancy
  • Collagen vascular disease (autoimmune disease) on medication
  • Renal disease
  • Epilepsy or other seizure disorder
  • Active or chronic liver disease
  • Heart disease, known illicit drug or alcohol abuse during current pregnancy
  • Already taking L-citrulline as a supplement (1gram/day or more)

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): NCT02772887


Locations
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United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Responsible Party: Robert Powers, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02772887    
Other Study ID Numbers: PRO15090627
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Powers, University of Pittsburgh:
pregnancy
type 2 diabetes
asymmetric dimethylarginine
L-arginine
L-citrulline
placental growth factor (PlGF)
blood pressure
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases