Nutritional Support During Antiviral Therapy for Hepatitis C

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00841243
• Other study ID #: 08-70
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 10, 2009
• Last updated: February 10, 2009
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2009
• Source: UMC Utrecht
• Contact: Karel van Erpecum, Dr
• Phone: 031-88756275
• Email: k.j.vanerpecum[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Netherlands	UMC	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

Plank 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		1 year	No