evidence-based blog of Filippo Dibari

Nutritional support for African adults starting antiretroviral therapy (NUSTART) – a clinical trial

In Under-nutrition on May 5, 2012 at 2:37 pm

Background of the Trial. Micronutrient deficiencies and altered mineral metabolism associated with wasting malnutrition are potential risk factors for death among African patients referred for anti‐retroviral therapy (ART). We will conduct a randomized controlled phase III trial of a lipid‐based nutrient supplement (LNS)* without or with vitamins and bulk minerals during the first weeks after referral for ART.

* Also known as lipid-based, ready-to-use food for nutrition rehabilitation.

“A number of important universities is conducting an interesting randomized controlled clinical trial to test a lipid-base, ready-to-use food in adults, ART naive, with BMI < 18.5 kg/m2, requiring ART as determined by CD4 count < 350/l. The primary outcome consists of survival from the time of referral for ART to 12 weeks after starting ART, whereas the secondary outcomes are hospitalization from referral for ART to 12 weeks after starting ART, gain in lean body mass, and change in serum phosphate.

“All participants will receive a stepped regimen of LNS: this comprises a small daily dose of LNS (SDLNS) containing limited calories, from time of referral for ART through the pre‐ART preparation phase and until 2 weeks after start of ART, and then a larger daily dose of LNS containing a greater calorie provision (LD‐LNS) for four weeks, i.e., from 2 to 6 weeks after start of ART.

“The investigators are: Professor Suzanne Filteau (principal investigator), London School of Hygiene & Tropical Medicine; Professor Henrik Friis, University of Copenhagen; Dr Paul Kelly, Barts & The London School of Medicine and University Teaching Hospital, Lusaka; Dr Lackson Kasonka, University Teaching Hospital, Lusaka; Mr John Changalucha, Mwanza Medical Research Centre, Tanzania; Dr. Tsinuel Girma. Jimma University Specialised Hospital, Ethiopia; Dr. Douglas Heimburger, Vanderbilt University, USA; Dr. Aase Bengaard Andersen, University of Odense, Denmark; Dr. John Koethe, Vanderbilt University, USA.”

More informations are available on this document.

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