Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01965054
Status:
WITHDRAWN
Last Update Posted:
2013-10-18
First Post:
2013-10-11
Brief Title:
The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy
Status:
WITHDRAWN
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Logistics unresolved at the IRB at Elmhurst Hospital
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intrahepatic cholestasis of pregnancy ICP is a unique disease of the liver resulting in abnormal bile acid levels and liver function The incidence of ICP ranges from 01 - 156 Women diagnosed with ICP most often present with itching which may be severe More concerning however is the impact of ICP on adverse fetal and pregnancy outcomes including preterm delivery meconium exposure fetal demise and increased neonatal respiratory complications The risk for fetal demise has been estimated to be 1-3 The mechanism of fetal demise in ICP is unknown and therefore cannot be reliably predicted There is evidence to suggest that extremely elevated bile acids levels are associated with worse fetal outcomes particularly levels greater than 40 μmolL
Ursodeoxycholic acid UDCA has anticholestatic effects and is used to treat a variety of cholestatic liver diseases Many studies have demonstrated superiority of UDCA over other agents including dexamethasone and cholestyramine for relief of maternal pruritus improvement in transaminitis reduction in serum bile acid concentrations and improved pregnancy outcomes As a result UDCA is now widely used as first-line treatment for symptomatic relief in patients with ICP
Docosahexaenoic acid DHA and eicosapentaenoic acid EPA are two omega-3 long chain polyunsaturated fatty acids found in fish DHA is known to play a key role in early fetal brain development and has been associated with modest beneficial effects on neurodevelopmental and cognitive outcomes in children In neonates with parental nutrition-induced cholestasis PN-cholestasis parental fish oil has been shown to be hepatoprotective not only for treatment of PN-cholestasis but for prevention of cholestasis in premature infants at risk for the disease Our hypothesis is that fish oil supplementation with DHA in women with ICP who are treated with UDCA will increase the rate of decline in serum total bile acid levels
The incidence of ICP at a single hospital center in Queens NY is estimated to be 5 secondary to a high concentration of patients from high-risk ethnic groups High risk patients with bile acid levels greater than or equal to 40 μmolL are managed aggressively with inpatient admission for continuous fetal monitoring treatment with UDCA and serial total bile acid levels weekly These are patients are routinely offered early delivery after documented fetal lung maturity between 36 and 37 weeks gestation or for any signs of fetal distress This study is a prospective randomized controlled trial comparing weekly serum total bile acid levels in women admitted for inpatient management of ICP among women supplemented with a standard prenatal vitamin versus supplementation with a prenatal vitamin and DHA
Ursodeoxycholic acid UDCA has anticholestatic effects and is used to treat a variety of cholestatic liver diseases Many studies have demonstrated superiority of UDCA over other agents including dexamethasone and cholestyramine for relief of maternal pruritus improvement in transaminitis reduction in serum bile acid concentrations and improved pregnancy outcomes As a result UDCA is now widely used as first-line treatment for symptomatic relief in patients with ICP
Docosahexaenoic acid DHA and eicosapentaenoic acid EPA are two omega-3 long chain polyunsaturated fatty acids found in fish DHA is known to play a key role in early fetal brain development and has been associated with modest beneficial effects on neurodevelopmental and cognitive outcomes in children In neonates with parental nutrition-induced cholestasis PN-cholestasis parental fish oil has been shown to be hepatoprotective not only for treatment of PN-cholestasis but for prevention of cholestasis in premature infants at risk for the disease Our hypothesis is that fish oil supplementation with DHA in women with ICP who are treated with UDCA will increase the rate of decline in serum total bile acid levels
The incidence of ICP at a single hospital center in Queens NY is estimated to be 5 secondary to a high concentration of patients from high-risk ethnic groups High risk patients with bile acid levels greater than or equal to 40 μmolL are managed aggressively with inpatient admission for continuous fetal monitoring treatment with UDCA and serial total bile acid levels weekly These are patients are routinely offered early delivery after documented fetal lung maturity between 36 and 37 weeks gestation or for any signs of fetal distress This study is a prospective randomized controlled trial comparing weekly serum total bile acid levels in women admitted for inpatient management of ICP among women supplemented with a standard prenatal vitamin versus supplementation with a prenatal vitamin and DHA
Detailed Description:
Intrahepatic cholestasis of pregnancy ICP is a unique disease of the liver resulting in abnormal bile acid levels and liver function In the literature the incidence of ICP ranges from 01 - 1561 Women diagnosed with ICP most often present with itching which may be severe More concerning however is the impact of ICP on adverse fetal and pregnancy outcomes including preterm delivery meconium exposure fetal demise and increased neonatal respiratory complications The risk for fetal demise has been estimated to be 1-3 The mechanism of fetal demise in ICP is unknown and therefore cannot be reliably predicted There is evidence to suggest that extremely elevated bile acids levels are associated with worse fetal outcomes particularly levels greater than 40 μmolL3 Ursodeoxycholic acid UDCA improves impaired hepatocellular secretion by stimulating canalicular bile acid transporter protein expression and is now widely used as first-line treatment for symptomatic relief in patients with ICP 1 Docosahexaenoic acid DHA and eicosapentaenoic acid EPA are two omega-3 long chain polyunsaturated fatty acids found in fish DHA is known to play a key role in early fetal brain development and has been associated with modest beneficial effects on neurodevelopmental and cognitive outcomes in children2 In neonates with parental nutrition-induced cholestasis PN-cholestasis parental fish oil has been shown to be hepatoprotective not only for treatment of PN-cholestasis but for prevention of cholestasis in premature infants at risk for the disease3-5 The incidence of ICP at a single hospital center in Queens NY is estimated to be 5 secondary to a high concentration of patients from high-risk ethnic groups High risk patients with bile acid levels greater than or equal to 40 μmolL are managed aggressively with inpatient admission for continuous fetal monitoring treatment with UDCA and serial total bile acid levels weekly and are routinely offered early delivery after documented fetal lung maturity between 36 and 37 weeks gestation or for any signs of fetal distress This study is a prospective randomized trial of women diagnosed with ICP prior to 36 weeks who are admitted to Elmhurst Hospital for inpatient observation Women will be randomized to receiving a standard prenatal vitamin daily or a prenatal vitamin plus fish oil supplementation in addition to the standard UDCA 300mg by mouth three times daily Dietary fish intake for each subject will be recorded Total bile acid serum levels will be followed weekly and fetal monitoring with daily non-stress tests will be performed on all women as per standard care for ICP at Elmhurst hospital The primary outcome of interest is a 20 reduction in serum total bile acid levels in the treatment group compared to the control group at each time point Secondary outcomes of interest include changes in maternal symptoms as measured using a validated itching score changes in UDCA dosing length of hospital stay and neonatal outcomes including gestational age at delivery Apgar scores neonatal intensive care unit admissions neonatal length of stay meconium aspiration birth weight and perinatal mortality Assuming 80 statistical power and a significance level of 005 to detect a 20 reduction in serum total bile acids in the treatment group compared to the placebo group a total of 100 patients in each arm is needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None