Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA

Malnutrition Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433743
• Other study ID #: UCheikhAntaDiop
• Status: Completed
• Phase: N/A
• First received: April 18, 2015
• Last updated: April 29, 2015
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2015
• Source: Cheikh Anta Diop University, Senegal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV-infection/Aids
• Malnutrition

Intervention

Dietary Supplement:
• Ready-to-use therapeutic food (RUTF)
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

Locations

Country	Name	City	State
Senegal	University Cheikh Anta Diop	Dakar

Sponsors (2)

Lead Sponsor	Collaborator
Cheikh Anta Diop University, Senegal	UNICEF

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body composition at 9 weeks	Body composition was measured using Bio-impedance analysis method at baseline, and 9 weeks home-based follow-up in both supplemented and control groups	9 weeks	Yes
Secondary	Change from baseline on anemia at 3 weeks	Hemoglobin was measured by Hemocue photometer at baseline and 3 week after admission in both supplemented and control groups	3 weeks	Yes
Secondary	Change from baseline on anemia at 9 weeks	Hemoglobin was measured by Hemocue photometer at baseline and after 9 weeks home-based follow-up in both supplemented and control groups	9 weeks	Yes
Secondary	Change from baseline on plasma zinc concentration at 3 weeks	Plasma zinc concentration was determined by Atomic absorption spectrometry at baseline and 3 weeks after admission in both supplemented and control groups	3 weeks	Yes
Secondary	Change from baseline on plasma zinc concentration at 9 weeks	Plasma zinc concentration was determined by Atomic absorption spectrometry at baseline and after 9 weeks home-based follow-up in both supplemented and control groups	9 weeks	Yes