Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA
Condition: HIV-infection/Aids; Malnutrition
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Anemia; Malnutrition
Study type: Interventional

Summary: 
      A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital
      diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group:
      n=32). Individual dietary intakes were measured and compared to the Recommended Dietary
      Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA),
      hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and
      adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and
      after 9 weeks home-based follow up.
    

Detailed description: 
      The sample size of the study (n=17 in each group) was calculated takin into account the mean
      gain of fat free mass (2.3± 2.1 kg) obtained in a study of PLWH supplemented with 43 g of
      RUTF/day. The randomization was performed upon admission using a computer-generated random
      number list (EPI INFO 6.0; Centers for Disease Control and Prevention, Atlanta).

      Dietary intakes were measured during 7 consecutive days in 10 subjects of each group during
      the hospitalization period. Each meal served was weighed with a food scale (i-Balance 2600
      Myweigh, Phoenix, USA).

      Anthropometrics measurement was performed using standard procedures. Measure of height was
      made using height board (SECA 216, GmbH et Co, Hamburg, Germany), to the nearest millimeter.
      Body weight was measured with an electronic scale (SECA 877, GmbH & Co, Hamburg, Germany).

      Body composition was measured using a multifrequency analyser, Xitron 4000B. The accuracy of
      the instrument was tested before the measurements by using a 422 ohm standard resistor
      purchased with the analyzer. Blood sampling was performed in the morning between 8 -10 AM
      into trace element-free polyethylene tubes zinc-free containing lithium heparin
      anticoagulant. The time of the sample collection and of the most recent food or milk intake
      were noted and used to adjust for this interval in the analysis of data. All the parameters
      were mesured in duplicate on admission, at 3 weeks and 9 weeks home based follup up.

      Double entry data, and quality control of the entry were performed using Epi-Info version
      3.5.1 (CDC, Atlanta, USA) and access. Statistical analysis was performed by Excel 2003
      (Microsoft Corporation, Redmond, USA) and STATA / SE 11.0 (Stata Corporation, Texas, and
      USA). Results are expressed as mean ± standard deviation and percentage. PZ concentration was
      adjusted for the time interval between the last meal and the blood drawing to minimize the
      variability due to the known meal-related effects on PZ concentration and from
      infections/inflammation [28]. Zinc deficiency was defined according to IZINCG cut-off. ANOVA
      followed by post-hoc Bonferroni tests for pairwise comparison of means or Student's t-test
      were also used on dependent measures. The Pearson Chi2 test or Fisher's exact test were used
      to compare percentages. P values 0.05 were considered as significant.
    

Intervention name(s): Ready-to-use therapeutic food (RUTF)
Intervention type(s): Dietary Supplement
Intervention description(s): HIV-infected patients were randomly allocated to receive standard hospital diet (Control: n=33), or this diet combined with 100 g/day of RUTF (RUTF: n=32). All patients was follow-up during hospitalisation and 9 week after discharge at home
Other intervention name(s): RUTF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HIV/AIDS; RUTF; fat free mass; anemia; zinc; Senegal