The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy
|ClinicalTrials.gov Identifier: NCT01965054|
Recruitment Status : Withdrawn (Logistics unresolved at the IRB at Elmhurst Hospital)
First Posted : October 18, 2013
Last Update Posted : October 18, 2013
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 0.1 - 15.6%. 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 μmol/L.
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 μmol/L 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.
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholestasis of Pregnancy||Dietary Supplement: Fish Oil Supplement Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Fish Oil Supplement Group
Receive the daily DHA pill and given a validated Itching Survey to assess maternal symptoms on admission and then weekly thereafter
Dietary Supplement: Fish Oil Supplement Group
1 liquid gel pill (440mg omega-3 fatty acids from fish oil) taken daily, enrollment to delivery
No Intervention: Control Group
Given a validated Itching Survey to assess maternal symptoms on admission and then weekly thereafter.
- Bile acid levels [ Time Frame: up to 9 months ]reduction in bile acid levels. Weekly (as part of standard hospital laboratory protocol for admission with intrahepatic cholestasis of pregnancy)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965054
|Principal Investigator:||Katherine Kohari, MD||Icahn School of Medicine at Mount Sinai|