Glomerular Injury of Preeclampsia
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|ClinicalTrials.gov Identifier: NCT00275158|
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : January 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pre-Eclampsia||Drug: L-Arginine Supplementation||Not Applicable|
OBJECTIVE: To assess the benefit of L-arginine, the precursor to nitric oxide (NO), to blood pressure and recovery of the glomerular lesion in pre-eclampsia.
METHODS: 45 women with pre-eclampsia were randomized to receive either L-arginine or placebo until day 10 post-partum. Primary outcome measures including MAP, glomerular filtration rate and proteinuria were assessed on the third and tenth days postpartum by inulin clearance and albumin-to-creatinine (A/C) ratio. NO, cyclic guanosine 3'5' monophosphate (cGMP), endothelin-1 (ET) and asymmetric-dimethyl-arginine (ADMA) and arginine levels were assayed prior to delivery, on the third and tenth day postpartum. Healthy gravid women provided control values. Assuming a standard deviation of 10 mmHg, the study was powered to detect a 10 mmHg difference in MAP (alpha 0.05, beta 0.20) between the study groups.
RESULTS: No significant differences existed between the groups with pre-eclampsia prior to randomization. Compared to the gravid control group, women with pre-eclampsia did not reveal significantly depressed levels of serum arginine, but did reveal significantly increased serum levels of ET, cGMP and ADMA prior to delivery. Despite a significant increase in serum arginine levels due to treatment, no differences were found in the levels of NO, ET, cGMP or ADMA between the two groups with pre-eclampsia. Further, there were no significant differences in any of the primary outcome measures with both groups demonstrating equivalent improvements in both blood pressure and proteinuria.
CONCLUSION: Blood pressure and kidney function improve markedly in pre-eclampsia by the tenth day postpartum. L-arginine supplementation does not hasten this recovery.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of L-Arginine Therapy on the Glomerular Injury of Pre-Eclampsia: A Randomized Controlled Trial|
|Study Start Date :||January 2000|
|Actual Study Completion Date :||December 2003|
- Mean Arterial Pressure
- Glomerular Filtration Rate (inulin clearance)
- Proteinuria (albumin to creatinine ratio)
- Vasoactive hormone levels - Nitric Oxide, Endothelin, cGMP, ADMA
- Neonatal Outcomes
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): NCT00275158
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Principal Investigator:||Bryan D Myers, MD||Stanford University|