PreeclampsiaPhase 3NCT02363348
Efficacy and Safety of L Arginine to Prevent Preeclampsia
A Phase 3 study testing L arginine in people with Preeclampsia, run by Hospital Civil Juan I. Menchaca at 1 site in Mexico.
Trial summary
Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia. applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- L arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2010to Mar 2014
- Phase
- Phase 3
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)
Who cannot join
- pregnant women carriers of chronic renal failure
- pre gestational diabetes
- multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia.
applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes
Read the detailed description
Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo.
Each three weeks were evaluated in search of high blood pressure and proteinuria.
The follow-up was until the end of pregnancy and two weeks after this
- Conditions
- Preeclampsia
- Being tested
- L arginine, Placebo
- Keywords
- L arginine, Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L arginineDietary supplement
L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.
PlaceboOther
calcined magnesia
| Study group | Role | What they receive |
|---|---|---|
| Placebo (A) | Placebo comparator | were administered 5 capsules per day each capsule contained 600 mg of magnesia calcinada. Duration: from week 20th of pregnancy until the end of the same.
dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner. Receives: Other: Placebo |
| L arginine (B) | Experimental | were administered 5 capsules per day each capsule contained 600 mg of L arginine. Duration: from week 20th of pregnancy until the end of the same dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner. Receives: Dietary Supplement: L arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of L arginine to prevent preeclampsia
number of patients with diagnosis of preeclampsia. the diagnostic was performed when they presented arterial blood pressure above 140/90 mm / Hg in the span of 6 hours and accompanied by proteinuria (>300 milligrams in one sample) number of patients with high blood pression and proteinuria (ACOG criteria) The evaluations were performed every three weeks until week 31, then every two weeks until week 35 and weekly until pregnancy ended
Measured: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.
Secondary outcomes (2)
perinatal outcome
number of patients with adverse perinatal outcome: APGAR scale < 7 at five minutes, low weight for gestational age (< 10 percentile) and CAPURRO scale < 37 weeks also the need to enter the neonatal intensive care unit
Measured: from time to delivery until two weeks after, approximalety 18 weeks
safety of L arginine
number of patients with adverse reactions and/or any alteration of blood test. participants are awarded a diary which recorded the symptoms that caused them any discomfort. If the discomfort was important it was reported via telephone with the treating physician. the paper was reviewed at each appointment. Blood tests such as blood count, liver function tests and kidney were performed every three weeks in search of alterations in the parameters considered normal by those tests (ACOG criteria)
Measured: from time of randomization until birth approximalety 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil Juan I. Menchaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Elizabet Camarena Pulido, Hospital Civil Juan I. Menchaca
- Investigators
- Guadalupe Panduro, Ph, Study chair, Hospital Civil Juan I. Menchaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363348
- Sponsor's protocol ID
- SSJ1054-11
- Status last verified
- Mar 2016
- First submitted
- 27 Jan 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johal T, Lees CC, Everett TR, Wilkinson IB. The nitric oxide pathway and possible therapeutic options in pre-eclampsia. Br J Clin Pharmacol. 2014 Aug;78(2):244-57. doi: 10.1111/bcp.12301.
PubMed 24313856Vadillo-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 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT02363348
- Acronym / sponsor ID
- SSJ1054-11
- Conditions
- Preeclampsia
- Keywords
- L arginine, Preeclampsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospital Civil Juan I. MenchacaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 Feb 2015 (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.
Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia.
applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes
Detailed description
Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo.
Each three weeks were evaluated in search of high blood pressure and proteinuria.
The follow-up was until the end of pregnancy and two weeks after this
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (A) | Placebo comparator | Other: Placebowere administered 5 capsules per day each capsule contained 600 mg of magnesia calcinada. Duration: from week 20th of pregnancy until the end of the same. dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner. |
| L arginine (B) | Experimental | Dietary Supplement: L argininewere administered 5 capsules per day each capsule contained 600 mg of L arginine. Duration: from week 20th of pregnancy until the end of the same dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)
Key exclusion criteria (3 listed)
- pregnant women carriers of chronic renal failure
- pre gestational diabetes
- multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)
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 arginineL arginine is a basic amino-acid precursor of nitric oxide main vasodilator. | Dietary supplement | L arginine (B) |
| Placebocalcined magnesia | Other | Placebo (A) |
Primary outcome
efficacy of L arginine to prevent preeclampsia
Time frame: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.
number of patients with diagnosis of preeclampsia. the diagnostic was performed when they presented arterial blood pressure above 140/90 mm / Hg in the span of 6 hours and accompanied by proteinuria (>300 milligrams in one sample) number of patients with high blood pression and proteinuria (ACOG criteria) The evaluations were performed every three weeks until week 31, then every two weeks until week 35 and weekly until pregnancy ended
2 secondary outcomes
perinatal outcome
Time frame: from time to delivery until two weeks after, approximalety 18 weeks
safety of L arginine
Time frame: from time of randomization until birth approximalety 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Background: PubMed 24313856Johal T, Lees CC, Everett TR, Wilkinson IB. The nitric oxide pathway and possible therapeutic options in pre-eclampsia. Br J Clin Pharmacol. 2014 Aug;78(2):244-57. doi: 10.1111/bcp.12301.
- Results publication: 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.
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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.
Guadalupe Panduro, Ph study chair
Hospital Civil Juan I. Menchaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L arginine in people with Preeclampsia, run by Hospital Civil Juan I. Menchaca at 1 site in Mexico.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy of L arginine to prevent preeclampsia (time frame: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.). 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 NCT02363348, which also lists 2 linked publications.
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 4 Mar 2016.