Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA (PLWHA)
Primary Purpose
HIV-infection/Aids, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Ready-to-use therapeutic food (RUTF)
Sponsored by
About this trial
This is an interventional supportive care trial for HIV-infection/Aids focused on measuring HIV/AIDS, RUTF, fat free mass, anemia, zinc, Senegal
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
Sites / Locations
- University Cheikh Anta Diop
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Ready-to-use therapeutic food (RUTF)
Arm Description
Control group (n=33) didn't received intervention. The received the standard hospital diet
RUTF group (n=32) received the standard hospital diet combined with 100 g/day of RUTF
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT02433743
First Posted
April 18, 2015
Last Updated
April 29, 2015
Sponsor
Cheikh Anta Diop University, Senegal
Collaborators
UNICEF
1. Study Identification
Unique Protocol Identification Number
NCT02433743
Brief Title
Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA
Acronym
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cheikh Anta Diop University, Senegal
Collaborators
UNICEF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-infection/Aids, Malnutrition
Keywords
HIV/AIDS, RUTF, fat free mass, anemia, zinc, Senegal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group (n=33) didn't received intervention. The received the standard hospital diet
Arm Title
Ready-to-use therapeutic food (RUTF)
Arm Type
Experimental
Arm Description
RUTF group (n=32) received the standard hospital diet combined with 100 g/day of RUTF
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-use therapeutic food (RUTF)
Other Intervention Name(s)
RUTF
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in body composition at 9 weeks
Description
Body composition was measured using Bio-impedance analysis method at baseline, and 9 weeks home-based follow-up in both supplemented and control groups
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Change from baseline on anemia at 3 weeks
Description
Hemoglobin was measured by Hemocue photometer at baseline and 3 week after admission in both supplemented and control groups
Time Frame
3 weeks
Title
Change from baseline on anemia at 9 weeks
Description
Hemoglobin was measured by Hemocue photometer at baseline and after 9 weeks home-based follow-up in both supplemented and control groups
Time Frame
9 weeks
Title
Change from baseline on plasma zinc concentration at 3 weeks
Description
Plasma zinc concentration was determined by Atomic absorption spectrometry at baseline and 3 weeks after admission in both supplemented and control groups
Time Frame
3 weeks
Title
Change from baseline on plasma zinc concentration at 9 weeks
Description
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
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salimata Wade, Professor
Organizational Affiliation
Université Cheikh Anta Diop de Dakar
Official's Role
Study Director
Facility Information:
Facility Name
University Cheikh Anta Diop
City
Dakar
Country
Senegal
12. IPD Sharing Statement
Citations:
PubMed Identifier
26728978
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.
Results Reference
derived
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Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA
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