CholestasisPhase 2/3MILOveNCT01247012
Minimization of IntraLipid Versus Omegaven
A Phase 2/3 study testing Omegaven and Lipid minimization in people with Cholestasis and Parenteral Nutrition Associated Liver Disease (PNALD), run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
Trial summary
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)
- What is being tested?
- Omegaven and Lipid minimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants admitted to neonatal intensive care unit
- severe cholestasis, defined as conjugated bilirubin greater than 35
- receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days
- signed consent
Who cannot join
- hepatitis (TORCH or other viral infection)
- primary liver disease as etiology of cholestasis
- clinically severe bleeding not able to be managed with routine measures
- lethal congenital abnormalities
- congenital heart disease associated with right heart dysfunction
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's & Women's Health Centre of BC
Vancouver, British Columbia
Jennifer Claydon, jclaydon@cw.bc.ca
About this study
Official title: A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.
Read the detailed description
Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises >100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).
- Being tested
- Omegaven, Lipid minimization
- Medical subject headings
- Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDietary supplement
Omegaven 1g/kg/day until infant receiving full enteral feeds
Lipid minimizationDietary supplement
1g/kg/day daily until infant receiving full enteral feeds
IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| Lipid minimization | Active comparator | Not described Receives: Dietary Supplement: Lipid minimization |
| Omegaven | Experimental | Not described Receives: Dietary Supplement: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
"Success" of the pilot trial will be determined by reaching the following criteria: 98.5% of subjects receive the modified lipid therapy within 12 to 24h of randomization; and/or 90% of subjects had their labs taken at the appropriate times as detailed by the study protocol.
Measured: up to 1 year
Clinical endpoint
The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization
Measured: up to 1 year
Secondary outcomes (2)
Total duration of parenteral nutrition
Measured: up to 1 year
Growth
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholestasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's & Women's Health Centre of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Family Research Institute
- Investigators
- Susan Albersheim, MD, PhD, Principal investigator, Children's & Women's Health Centre of BCAvash J Singh, MD, Principal investigator, Children's & Women's Health Centre of BCRebecca Sherlock, MD, Principal investigator, Children's & Women's Health Centre of BC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247012
- Sponsor's protocol ID
- MILOVE-134698
- Acronym
- MILOve
- Status last verified
- Sep 2011
- First submitted
- 23 Nov 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial
- ClinicalTrials.gov ID
- NCT01247012
- Acronym / sponsor ID
- MILOve / MILOVE-134698
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's & Women's Health Centre of British ColumbiaUniversity, hospital or other
- Collaborators
- Child and Family Research Institute
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.
Detailed description
Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises >100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipid minimization | Active comparator | Dietary Supplement: Lipid minimization |
| Omegaven | Experimental | Dietary Supplement: Omegaven |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- infants admitted to neonatal intensive care unit
- severe cholestasis, defined as conjugated bilirubin greater than 35
- receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days
- signed consent
Key exclusion criteria (5 listed)
- hepatitis (TORCH or other viral infection)
- primary liver disease as etiology of cholestasis
- clinically severe bleeding not able to be managed with routine measures
- lethal congenital abnormalities
- congenital heart disease associated with right heart dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmegavenOmegaven 1g/kg/day until infant receiving full enteral feeds | Dietary supplement | Omegaven |
| Lipid minimization1g/kg/day daily until infant receiving full enteral feeds IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day) | Dietary supplement | Lipid minimization |
Primary outcome
Feasibility
Time frame: up to 1 year
"Success" of the pilot trial will be determined by reaching the following criteria: 98.5% of subjects receive the modified lipid therapy within 12 to 24h of randomization; and/or 90% of subjects had their labs taken at the appropriate times as detailed by the study protocol.
Clinical endpoint
Time frame: up to 1 year
The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization
2 secondary outcomes
Total duration of parenteral nutrition
Time frame: up to 1 year
Growth
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Albersheim, MD, PhD principal investigator
Children's & Women's Health Centre of BC
Avash J Singh, MD principal investigator
Children's & Women's Health Centre of BC
Rebecca Sherlock, MD principal investigator
Children's & Women's Health Centre of BC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omegaven and Lipid minimization in people with Cholestasis and Parenteral Nutrition Associated Liver Disease (PNALD), run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.