The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy

NCT01965054 | Withdrawn

• 1 other identifier: GCO 12-1542
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

Intrahepatic cholestasis of pregnancy; fish oil; omega-3; Docosahexaenoic acid,; eicosapentaenoic acid

Outcome Measures

Primary Outcomes (1)

• Bile acid levels

  reduction in bile acid levels. Weekly (as part of standard hospital laboratory protocol for admission with intrahepatic cholestasis of pregnancy)

  up to 9 months

Study Arms (2)

Fish Oil Supplement Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Given a validated Itching Survey to assess maternal symptoms on admission and then weekly thereafter.

Interventions

Fish Oil Supplement Group DIETARY_SUPPLEMENT

1 liquid gel pill (440mg omega-3 fatty acids from fish oil) taken daily, enrollment to delivery

Also known as: DHA, Docosahexaenoic acid, Women's One A Day

Fish Oil Supplement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All pregnant women aged 18 years or older admitted to Elmhurst Hospital Center (EHC) for inpatient management of ICP due to a serum total bile acid level \> 40 μmol/L, or serum total bile acid level \> 10 μmol/L with elevated AST or ALT, are eligible for enrollment

You may not qualify if:

• Women \< 18 years
• Women with allergies to fish

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Related Publications (1)

• Walker KF, Chappell LC, Hague WM, Middleton P, Thornton JG. Pharmacological interventions for treating intrahepatic cholestasis of pregnancy. Cochrane Database Syst Rev. 2020 Jul 27;7(7):CD000493. doi: 10.1002/14651858.CD000493.pub3.

  PMID: 32716060 DERIVED

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Katherine Kohari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 18, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 18, 2013

Record last verified: 2013-10