Pre-EclampsiaPhase 2L-ArgNCT00469846
L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia
A Phase 2 study testing L-arginine supplementation in a medical food and Vitamin C and E supplementation in a medical food in people with Pre-Eclampsia, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 2 sites in 2 countries.
Trial summary
This study is intended to assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population. Read more about this study
- Who is it for?
- Ages 19 to 32 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- L-arginine supplementation in a medical food and Vitamin C and E supplementation in a medical food
- Type of treatment
- Surgery or procedure
- How many people
- 585 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2001to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 32 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Previous pregnancy complicated with pre-eclampsia/eclampsia
- Singleton pregnancy
- Gestational age >20 weeks <34 weeks
- Protein excretion < 300 mg/day
Who cannot join
- Multiple gestation
- Major fetal anomaly
- Pre-existing hypertension
- Pre-existing renal disease
- Diabetes
- Collagen vascular disease
- Cancer or strong family history of cancer in first degree relatives
- Preexisting maternal disease requiring medication
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Univesity of Pennsylvania
Philadelphia, Pennsylvania, 19104-6142
Mexico1 site
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Mexico City, D.F., 11000
About this study
Official title: Supplementation With L-Arginine and Antioxidant Vitamins During Pregnancy in a Medical Food to Reduce the Risk of Preeclampsia in a High Risk Population
This study is intended to assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population.
Read the detailed description
Preeclampsia is a syndrome of unknown origin characterized by hypertension, edema and proteinuria. It usually appears in the third trimester and occurs most frequently in primigravidas. Preeclampsia may be complicated by life-threatening conditions including seizures, severe hepatic dysfunction, renal failure and coagulopathy; it is one of the leading causes of maternal morbidity and mortality worldwide. Preeclampsia is cited as the leading cause of maternal death in surveys of maternal mortality in Mexico (25% of maternal deaths).
Specific Aim 1. To assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population. Two other groups will receive the food (bars) either with antioxidant vitamins alone or without vitamins in order to test the impact of vitamin supplements on prevention of preeclampsia. The primary hypothesis to be tested is that supplemental L-arginine in combination with antioxidant vitamins will significantly reduce preeclampsia (hypertension and proteinuria) and its complications in a high-risk population (women whose blood pressure is > 140/90 after 20 weeks gestation without proteinuria). Secondary hypotheses to be tested include that antioxidant vitamin supplementation contributes to the reduction in preeclampsia; that supplemental L-arginine and antioxidant vitamins will improve neonatal outcomes (reduced incidence of prematurity and intrauterine growth retardation); that preeclampsia is correlated inversely with plasma L-arginine levels, directly with the plasma levels of the endogenous NO synthase inhibitor, asymmetric dimethyl arginine (ADMA), and inversely with urinary NO metabolites, a marker of endogenous NO production; and that preeclampsia is inversely correlated with maternal plasma levels of antioxidant vitamins.
- Conditions
- Pre-Eclampsia
- Being tested
- L-arginine supplementation in a medical food, Vitamin C and E supplementation in a medical food
- Keywords
- Pre-Eclampsia, Hypertension,pregnancy-induced, Preterm labor
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginine supplementation in a medical foodProcedure or surgery
Vitamin C and E supplementation in a medical foodProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of preeclampsia
Measured: During pregnancy
Secondary outcomes (4)
Development of eclampsia
Measured: During pregnancy
Occurrence of HELP syndrome
Measured: During pregnancy
Occurrence of preterm labor, preterm premature rupture of the membranes
Measured: During pregnancy
Gestational age at delivery
Measured: End of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startJan 2001
- Study completionNov 2006
Why it stopped: Recruitment and follow-up has been completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Collaborators
- University of Pennsylvania, Bill and Melinda Gates Foundation
- Investigators
- Felipe Vadillo-Ortega, M.D.,Ph.D., Principal investigator, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469846
- Sponsor's protocol ID
- 212250-02071
- Acronym
- L-Arg
- Status last verified
- Apr 2007
- First submitted
- 4 May 2007
- Last updated
- 8 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vadillo-Ortega F, Perichart-Perera O, Espino S, Avila-Vergara MA, Ibarra I, Ahued R, Godines M, Parry S, Macones G, Strauss JF. Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial. BMJ. 2011 May 19;342:d2901. doi: 10.1136/bmj.d2901.
PubMed 21596735
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With L-Arginine and Antioxidant Vitamins During Pregnancy in a Medical Food to Reduce the Risk of Preeclampsia in a High Risk Population
- ClinicalTrials.gov ID
- NCT00469846
- Acronym / sponsor ID
- L-Arg / 212250-02071
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-Eclampsia, Hypertension,pregnancy-induced, Preterm labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and follow-up has been completed.
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Collaborators
- University of Pennsylvania, Bill and Melinda Gates Foundation
- Study start
- Jan 2001
- Study completion
- Nov 2006 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population.
Detailed description
Preeclampsia is a syndrome of unknown origin characterized by hypertension, edema and proteinuria. It usually appears in the third trimester and occurs most frequently in primigravidas. Preeclampsia may be complicated by life-threatening conditions including seizures, severe hepatic dysfunction, renal failure and coagulopathy; it is one of the leading causes of maternal morbidity and mortality worldwide. Preeclampsia is cited as the leading cause of maternal death in surveys of maternal mortality in Mexico (25% of maternal deaths).
Specific Aim 1. To assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population. Two other groups will receive the food (bars) either with antioxidant vitamins alone or without vitamins in order to test the impact of vitamin supplements on prevention of preeclampsia. The primary hypothesis to be tested is that supplemental L-arginine in combination with antioxidant vitamins will significantly reduce preeclampsia (hypertension and proteinuria) and its complications in a high-risk population (women whose blood pressure is > 140/90 after 20 weeks gestation without proteinuria). Secondary hypotheses to be tested include that antioxidant vitamin supplementation contributes to the reduction in preeclampsia; that supplemental L-arginine and antioxidant vitamins will improve neonatal outcomes (reduced incidence of prematurity and intrauterine growth retardation); that preeclampsia is correlated inversely with plasma L-arginine levels, directly with the plasma levels of the endogenous NO synthase inhibitor, asymmetric dimethyl arginine (ADMA), and inversely with urinary NO metabolites, a marker of endogenous NO production; and that preeclampsia is inversely correlated with maternal plasma levels of antioxidant vitamins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 32 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Previous pregnancy complicated with pre-eclampsia/eclampsia
- Singleton pregnancy
- Gestational age >20 weeks <34 weeks
- Protein excretion < 300 mg/day
Key exclusion criteria (8 listed)
- Multiple gestation
- Major fetal anomaly
- Pre-existing hypertension
- Pre-existing renal disease
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginine supplementation in a medical food | Procedure or surgery | – |
| Vitamin C and E supplementation in a medical food | Procedure or surgery | – |
Primary outcome
Development of preeclampsia
Time frame: During pregnancy
4 secondary outcomes
Development of eclampsia
Time frame: During pregnancy
Occurrence of HELP syndrome
Time frame: During pregnancy
Occurrence of preterm labor, preterm premature rupture of the membranes
Time frame: During pregnancy
Gestational age at delivery
Time frame: End of pregnancy
Results and safety
The study was stopped early (reason given: Recruitment and follow-up has been completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2007.
- Derived from this study: PubMed 21596735Vadillo-Ortega F, Perichart-Perera O, Espino S, Avila-Vergara MA, Ibarra I, Ahued R, Godines M, Parry S, Macones G, Strauss JF. Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial. BMJ. 2011 May 19;342:d2901. doi: 10.1136/bmj.d2901.
Related trials for Pre-Eclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Vadillo-Ortega, M.D.,Ph.D. principal investigator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-arginine supplementation in a medical food and Vitamin C and E supplementation in a medical food in people with Pre-Eclampsia, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment and follow-up has been completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of preeclampsia (time frame: During pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2007.