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A randomised, double-blind, controlled study on the effect of one year administration of a nutritional concept on immunological status in human immunodeficiency virus-1 positive adults not on anti-retroviral therapy
ISRCTN ISRCTN81868024
DOI 10.1186/ISRCTN81868024
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised, double-blind, controlled study on the effect of one year administration of a nutritional concept on immunological status in human immunodeficiency virus-1 positive adults not on anti-retroviral therapy
Scientific title
Acronym BITE (Blinded nutritional study for Immunity and Tolerance Evaluation)
Serial number at source N/A
Study hypothesis Improving the immunological status of Human Immunodeficiency Virus-1 (HIV-1) infected adults not on antiretroviral therapy through nutritional support.
Lay summary Not provided at time of registration
Ethics approval Approval received from the Medisch Ethische Commissie AMC on the 20th September 2006 (ref: Internal Numico: 100157; Ethics board: MEC 06/199).
Study design Randomised, placebo controlled, parallel group, double blinded, multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain HIV
Participants - inclusion criteria Main inclusion criteria:
1. HIV-1 positive adults who have not received (Highly Active) Anti-Retroviral Therapy ([HA]ART) in the past year and are not anticipated to start therapy within the next six months
2. HIV-1 Ribonucleic Acid (RNA) more than 5,000 copies/ml in the three months prior to screening visit
3. CD4+ T-cell count less than or equal to 800 cells/µl in the three months prior to screening visit
4. More than or equal to 18 years old
Participants - exclusion criteria Main exclusion criteria:
1. (HA)ART anticipated to be required within the next six months
2. Unintended weight loss of more than 10% in the three months prior to screening visit
Anticipated start date 23/01/2007
Anticipated end date 30/04/2009
Status of trial Completed
Patient information material
Target number of participants 800
Interventions Intervention group:
A nutritional concept containing specific selected ingredients.

Control group:
Isocaloric nutritional product with an almost identical appearance and flavour as the investigational product though without the specific selected ingredients.

Patients will be supplied with either a nutritional test or a control product for a period of 12 months.
Primary outcome measure(s) Change from baseline in CD4+ T-cell count during 12 months.
Secondary outcome measure(s) Changes from baseline during one year in:
1. Immune markers other than CD4+ T-cell count
2. Viral load (HIV-1 RNA)
Sources of funding Numico Research B.V. (The Netherlands)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23511299
Contact name Mr  Remko  Hiemstra
  Address Numico Research B.V.
PO Box 7005
  City/town Wageningen
  Zip/Postcode 6700 CA
  Country Netherlands
  Tel +31 (0)317 467 991
  Fax +31 (0)317 466 500
  Email Remko.Hiemstra@numico-research.nl
Sponsor Numico Research B.V. (The Netherlands)
  Address P.O. Box 7005
  City/town Wageningen
  Zip/Postcode 6700 CA
  Country Netherlands
  Sponsor website: http://www.numico.com/en/
Date applied 26/02/2007
Last edited 06/01/2014
Date ISRCTN assigned 26/02/2007
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