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

NCT ID: NCT02433743

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-07-31

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.

Conditions

HIV-infection/Aids; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Control group (n=33) didn't received intervention. The received the standard hospital diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ready-to-use therapeutic food (RUTF)

RUTF group (n=32) received the standard hospital diet combined with 100 g/day of RUTF

Group Type: EXPERIMENTAL

Ready-to-use therapeutic food (RUTF)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

RUTF

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICEF

OTHER

Sponsor Role: collaborator

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role: lead

Responsible Party

Jean Louis Ndiaye

Adama Diouf

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salimata Wade, Professor

Role: STUDY_DIRECTOR

Université Cheikh Anta Diop de Dakar

Locations

University Cheikh Anta Diop

Dakar, , Senegal

Countries

Senegal

References

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.

Reference Type: DERIVED

PMID: 26728978 (View on PubMed)

Other Identifiers

UCheikhAntaDiop

Identifier Type: -

Identifier Source: org_study_id