Hepatitis CPhase 4NCT00841243
Nutritional Support During Antiviral Therapy for Hepatitis C
A Phase 4 study testing Nutrison (Nutricia) in people with Hepatitis C and Weight Loss, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Standard antiviral treatment consists of weekly injections with Peginterferon-α in combination with ribavirin. This treatment may lead to significant weight loss (7% within 24 weeks on average), with decreased quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Weight Loss
- What is being tested?
- Nutrison (Nutricia)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to Aug 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hepatitis C
- Indication for antiviral therapy
- Age > 18 years
- Good understanding of Dutch or English language
- Informed consent
Who cannot join
- Co-infection with hepatitis B and/or HIV
- Significant non hepatic diseases
- Significant previous surgery of the gastro-intestinal tract
- Hepatocellular carcinoma or other current malignant disease
- BMI < 20
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
UMC
Utrecht, 3509GA
Karel van Erpecum, MD, 031-88756275, k.j.vanerpecum@umcutrecht.nl
About this study
Official title: The Effects of Preventive Versus on Demand Nutritional Advice and Support on the Nutritional Status of Patients During Antiviral Therapy for Hepatitis C A Randomized, Multi Center Trial
Standard antiviral treatment consists of weekly injections with Peginterferon-α in combination with ribavirin. This treatment may lead to significant weight loss (7% within 24 weeks on average), with decreased quality of life. In this study the investigators will examine in 50 patients whether nutritional advise and support can prevent weight loss during antiviral therapy.
Read the detailed description
Standard antiviral treatment consists of weekly injections with Peginterferon-α in combination with ribavirin. This therapy, however, leads to weight loss of approximately 7% in the first 24 weeks of therapy possibly related to impaired postprandial gastric emptying. Such rapid weight loss is a marker of deterioration of the nutritional status with increased risk of complications and reduced immunological barrier function. Deterioration of the nutritional status also exacerbates side effects of the antiviral treatment like fatigue and depression. As a result, the quality of life of these patients may decrease. In the current controlled, prospective, multicenter, study we primarily aim to compare the effects of preventative versus on demand nutritional advice in combination with nutritional support on reduction of weight loss in patients receiving standard antiviral therapy with PEG-interferon in combination with ribavirin. We will randomize patients for the preventative intervention with dietary consultation combined with dietary supplementation of a daily snack or the on demand dietary support group (only dietary follow up, no dietary advice or snack, standard care). In the on demand group, patients will be referred to the dietitian in case of weight loss of ≥ 5% or a BMI < 20 during antiviral therapy. Assuming that 60% reduction of weight loss during the first 24 weeks of treatment is clinically relevant, 2 x 25 patients need to be included (α=0.05, β=0.2: power=0.8 and a drop-out rate of 15%). Primary aim is to assess whether the intervention can decrease the amount of weight loss during therapy.
- Conditions
- Hepatitis C, Weight Loss
- Being tested
- Nutrison (Nutricia)
- Keywords
- Hepatitis C, Antiviral therapy, weight loss, dietary support, dietary advise
- Medical subject headings
- Hepatitis C, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrison (Nutricia)Dietary supplement
Also called Nutridrink protein (Nutricia, The Netherlands)
During 48 weeks of treatment, the patient will receive at T=0, 2, 4, 8, 12, 18, 24, 36, 48 weeks dietary advise combined with daily nutritional support in the form of a nutritional supplement drink at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| nutritional advise/support | Active comparator | Nutritional advise and support Receives: Dietary Supplement: Nutrison (Nutricia) |
| control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Karel van Erpecum, Dr, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841243
- Sponsor's protocol ID
- 08-70
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kruizenga HM, Wierdsma NJ, van Bokhorst MA, de van der Schueren, Haollander HJ, Jonkers-Schuitema CF, van der Heijden E, Melis GC, van Staveren WA. Screening of nutritional status in The Netherlands. Clin Nutr. 2003 Apr;22(2):147-52. doi: 10.1054/clnu.2002.0611.
PubMed 12706131Plank LD, Gane EJ, Peng S, Muthu C, Mathur S, Gillanders L, McIlroy K, Donaghy AJ, McCall JL. Nocturnal nutritional supplementation improves total body protein status of patients with liver cirrhosis: a randomized 12-month trial. Hepatology. 2008 Aug;48(2):557-66. doi: 10.1002/hep.22367.
PubMed 18627001
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preventive Versus on Demand Nutritional Advice and Support on the Nutritional Status of Patients During Antiviral Therapy for Hepatitis C A Randomized, Multi Center Trial
- ClinicalTrials.gov ID
- NCT00841243
- Acronym / sponsor ID
- 08-70
- Conditions
- Hepatitis C, Weight Loss
- Keywords
- Hepatitis C, Antiviral therapy, weight loss, dietary support, dietary advise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 11 Feb 2009 (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.
Standard antiviral treatment consists of weekly injections with Peginterferon-α in combination with ribavirin. This treatment may lead to significant weight loss (7% within 24 weeks on average), with decreased quality of life. In this study the investigators will examine in 50 patients whether nutritional advise and support can prevent weight loss during antiviral therapy.
Detailed description
Standard antiviral treatment consists of weekly injections with Peginterferon-α in combination with ribavirin. This therapy, however, leads to weight loss of approximately 7% in the first 24 weeks of therapy possibly related to impaired postprandial gastric emptying. Such rapid weight loss is a marker of deterioration of the nutritional status with increased risk of complications and reduced immunological barrier function. Deterioration of the nutritional status also exacerbates side effects of the antiviral treatment like fatigue and depression. As a result, the quality of life of these patients may decrease. In the current controlled, prospective, multicenter, study we primarily aim to compare the effects of preventative versus on demand nutritional advice in combination with nutritional support on reduction of weight loss in patients receiving standard antiviral therapy with PEG-interferon in combination with ribavirin. We will randomize patients for the preventative intervention with dietary consultation combined with dietary supplementation of a daily snack or the on demand dietary support group (only dietary follow up, no dietary advice or snack, standard care). In the on demand group, patients will be referred to the dietitian in case of weight loss of ≥ 5% or a BMI < 20 during antiviral therapy. Assuming that 60% reduction of weight loss during the first 24 weeks of treatment is clinically relevant, 2 x 25 patients need to be included (α=0.05, β=0.2: power=0.8 and a drop-out rate of 15%). Primary aim is to assess whether the intervention can decrease the amount of weight loss during therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutritional advise/support | Active comparator | Dietary Supplement: Nutrison (Nutricia)Nutritional advise and support |
| control | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of hepatitis C
- Indication for antiviral therapy
- Age > 18 years
- Good understanding of Dutch or English language
- Informed consent
Key exclusion criteria (5 listed)
- Co-infection with hepatitis B and/or HIV
- Significant non hepatic diseases
- Significant previous surgery of the gastro-intestinal tract
- Hepatocellular carcinoma or other current malignant disease
- BMI < 20
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 |
|---|---|---|
| Nutrison (Nutricia)Also: Nutridrink protein (Nutricia, The Netherlands)During 48 weeks of treatment, the patient will receive at T=0, 2, 4, 8, 12, 18, 24, 36, 48 weeks dietary advise combined with daily nutritional support in the form of a nutritional supplement drink at bedtime. | Dietary supplement | nutritional advise/support |
Primary outcome
Weight loss
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
- Background: PubMed 12706131Kruizenga HM, Wierdsma NJ, van Bokhorst MA, de van der Schueren, Haollander HJ, Jonkers-Schuitema CF, van der Heijden E, Melis GC, van Staveren WA. Screening of nutritional status in The Netherlands. Clin Nutr. 2003 Apr;22(2):147-52. doi: 10.1054/clnu.2002.0611.
- Background: PubMed 18627001Plank LD, Gane EJ, Peng S, Muthu C, Mathur S, Gillanders L, McIlroy K, Donaghy AJ, McCall JL. Nocturnal nutritional supplementation improves total body protein status of patients with liver cirrhosis: a randomized 12-month trial. Hepatology. 2008 Aug;48(2):557-66. doi: 10.1002/hep.22367.
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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.
Karel van Erpecum, Dr principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutrison (Nutricia) in people with Hepatitis C and Weight Loss, run by UMC Utrecht at 1 site in Netherlands.
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 5 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 11 Feb 2009. 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 Netherlands. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Karel van Erpecum, Dr (031-88756275, k.j.vanerpecum@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841243, which also lists 2 linked publications.
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 11 Feb 2009.