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| Name | Class |
|---|---|
| Harvard University | OTHER |
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not
This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lovaza group | Experimental | Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day |
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| Placebo group | Placebo Comparator | Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovaza (omega-3-acid ethyl ester) | Drug | supplied as 1gram transparent soft-gelatin capsules filled with yellow oil, dosage is 1gram per kilogram of body weight per day, not exceeding 4grams per day until normalization of liver function test |
| Measure | Description | Time Frame |
|---|---|---|
| Normalization of ALT | The primary aim is to examine the efficacy of Lovaza, when compared to placebo, on normalizing liver function, as measured primarily by amino alanine transferase (ALT). The investigators believe that patients in the Lovaza group will normalize ALT faster than in the placebo group. |
| Measure | Description | Time Frame |
|---|---|---|
| Normalization other liver function tests and inflammatory status | The investigators believe that Lovaza will result in faster reduction of the serum levels of the following markers: total bilirubin, aspartate amino transferase (AST), alkaline phosphatase, gamma glutamyl transpeptidase (GGTP) & C-reactive protein (CRP). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Jaksic, MD, PhD | Children's Hopsital Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D005395 | Fish Oils |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
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| Corn oil | Dietary Supplement | 1 gram per kilogram body weight per day, not exceeding 4 grams |
|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005223 |
| Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |