Malnutrition Clinical Trial
Official title:
Daily Consumption of Ready-to-use Peanut-based Therapeutic Food Increased Fat Free Mass, Improved Anemia Status But Has no Impact on Zinc Status of People Living With HIV/AIDS (PLWHA)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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