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Nutritional Support During Antiviral Therapy for Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841243
Recruitment Status : Unknown
Verified February 2009 by UMC Utrecht.
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2009
Last Update Posted : February 11, 2009
Information provided by:
UMC Utrecht

Brief 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. In this study the investigators will examine in 50 patients whether nutritional advise and support can prevent weight loss during antiviral therapy.

Condition or disease Intervention/treatment Phase
Hepatitis C Weight Loss Dietary Supplement: Nutrison (Nutricia) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: nutritional advise/support
Nutritional advise and support
Dietary Supplement: Nutrison (Nutricia)
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.
Other Name: Nutridrink protein (Nutricia, The Netherlands)

No Intervention: control

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of hepatitis C
  • Indication for antiviral therapy
  • Age > 18 years
  • Good understanding of Dutch or English language
  • Informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00841243

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Contact: Karel van Erpecum, Dr 031-88756275

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Utrecht, Netherlands, 3509GA
Contact: Karel van Erpecum, MD    031-88756275   
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: Karel van Erpecum, Dr UMC Utrecht
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Responsible Party: Dr K.J. van Erpecum, UMC Utrecht Identifier: NCT00841243    
Other Study ID Numbers: 08-70
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by UMC Utrecht:
Hepatitis C
Antiviral therapy
weight loss
dietary support
dietary advise
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Weight Loss
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Body Weight Changes
Body Weight