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
  Purpose

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 Intervention Phase
Hepatitis C
Weight Loss
Dietary Supplement: Nutrison (Nutricia)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841243

Contacts
Contact: Karel van Erpecum, Dr 031-88756275 k.j.vanerpecum@umcutrecht.nl

Locations
Netherlands
UMC Not yet recruiting
Utrecht, Netherlands, 3509GA
Contact: Karel van Erpecum, MD    031-88756275    k.j.vanerpecum@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Karel van Erpecum, Dr UMC Utrecht
  More Information

Publications:
Responsible Party: Dr K.J. van Erpecum, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00841243     History of Changes
Other Study ID Numbers: 08-70
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Hepatitis C
Antiviral therapy
weight loss
dietary support
dietary advise

Additional relevant MeSH terms:
Hepatitis
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
Signs and Symptoms
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014