Clinical trial NCT02433743: Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-infection/Aids
Malnutrition
Keywords: HIV/AIDS
RUTF
fat free mass
anemia
zinc
Senegal
Lead sponsor: Cheikh Anta Diop University, Senegal
Sponsor class: OTHER
Collaborators: name: UNICEF
First posted: 2015-05-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* HIV/AIDS men and women
* at any WHO stages of HIV disease,
* under ART treatment or not,
* without psychiatric illness and not diabetic

Exclusion Criteria:

* confirmed HIV-negative,
* long term physical disability
* inability to eat

Primary outcomes:
measure: Change from baseline in body composition at 9 weeks
timeFrame: 9 weeks
Secondary outcomes:
measure: Change from baseline on anemia at 3 weeks
timeFrame: 3 weeks
measure: Change from baseline on anemia at 9 weeks
timeFrame: 9 weeks
measure: Change from baseline on plasma zinc concentration at 3 weeks
timeFrame: 3 weeks
measure: Change from baseline on plasma zinc concentration at 9 weeks
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: University Cheikh Anta Diop
Study officials:
affiliation: Université Cheikh Anta Diop de Dakar
name: Salimata Wade, Professor
role: STUDY_DIRECTOR
References:
citation: Diouf A, Badiane A, Manga NM, Idohou-Dossou N, Sow PS, Wade S. Daily consumption of ready-to-use peanut-based therapeutic food increased fat free mass, improved anemic status but has no impact on the zinc status of people living with HIV/AIDS: a randomized controlled trial. BMC Public Health. 2016 Jan 4;16:1. doi: 10.1186/s12889-015-2639-8.