Study Stopped
Inability to successfully recruit study participants
Nutraceutical Citrulline in Pregnancy
Phase 1 Trial Citrulline and Type 2 Diabetes in Pregnancy
1 other identifier
interventional
8
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Aug 2016
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 16, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMay 30, 2019
May 1, 2019
2.7 years
February 12, 2016
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure
research measure
approximately 20 weeks
Secondary Outcomes (1)
Placental growth factor (PlGF)
approximately 20 weeks
Study Arms (2)
Citrulline
EXPERIMENTALOral L-citrulline, 3 grams once per day for 3 weeks.
Placebo
PLACEBO COMPARATORPlacebo, 3 grams once per day for 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 12, 2016
First Posted
May 16, 2016
Study Start
August 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
May 30, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share