Nutritional Support During Antiviral Therapy for Hepatitis C

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by UMC Utrecht.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00841243
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 10, 2009
February 10, 2009
March 2009
March 2010   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Nutritional Support During Antiviral Therapy for Hepatitis C
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hepatitis C
  • Weight Loss
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)
  • Active Comparator: nutritional advise/support
    Nutritional advise and support
    Intervention: Dietary Supplement: Nutrison (Nutricia)
  • No Intervention: control
    Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
August 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Karel van Erpecum, Dr 031-88756275 k.j.vanerpecum@umcutrecht.nl
Netherlands
 
NCT00841243
08-70
Yes
Dr K.J. van Erpecum, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Karel van Erpecum, Dr UMC Utrecht
UMC Utrecht
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP