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

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ClinicalTrials.gov Identifier: NCT02433743
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
UNICEF
Information provided by (Responsible Party):
Jean Louis Ndiaye, Cheikh Anta Diop University, Senegal

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.

Condition or disease Intervention/treatment Phase
HIV-infection/Aids Malnutrition Dietary Supplement: Ready-to-use therapeutic food (RUTF) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : October 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia HIV/AIDS

Arm Intervention/treatment
No Intervention: Control
Control group (n=33) didn't received intervention. The received the standard hospital diet
Experimental: Ready-to-use therapeutic food (RUTF)
RUTF group (n=32) received the standard hospital diet combined with 100 g/day of RUTF
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
Other Name: RUTF




Primary Outcome Measures :
  1. Change from baseline in body composition at 9 weeks [ Time Frame: 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


Secondary Outcome Measures :
  1. Change from baseline on anemia at 3 weeks [ Time Frame: 3 weeks ]
    Hemoglobin was measured by Hemocue photometer at baseline and 3 week after admission in both supplemented and control groups

  2. Change from baseline on anemia at 9 weeks [ Time Frame: 9 weeks ]
    Hemoglobin was measured by Hemocue photometer at baseline and after 9 weeks home-based follow-up in both supplemented and control groups

  3. Change from baseline on plasma zinc concentration at 3 weeks [ Time Frame: 3 weeks ]
    Plasma zinc concentration was determined by Atomic absorption spectrometry at baseline and 3 weeks after admission in both supplemented and control groups

  4. Change from baseline on plasma zinc concentration at 9 weeks [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433743


Locations
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Senegal
University Cheikh Anta Diop
Dakar, Senegal
Sponsors and Collaborators
Cheikh Anta Diop University, Senegal
UNICEF
Investigators
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Study Director: Salimata Wade, Professor Université Cheikh Anta Diop de Dakar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jean Louis Ndiaye, Adama Diouf, Cheikh Anta Diop University, Senegal
ClinicalTrials.gov Identifier: NCT02433743     History of Changes
Other Study ID Numbers: UCheikhAntaDiop
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015
Keywords provided by Jean Louis Ndiaye, Cheikh Anta Diop University, Senegal:
HIV/AIDS
RUTF
fat free mass
anemia
zinc
Senegal
Additional relevant MeSH terms:
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Anemia
Malnutrition
Hematologic Diseases
Nutrition Disorders
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs