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1
Impacts of Specialized Food Products on HIV-infected Adults
and Malnourished Children: Emerging Evidence from
Randomized Trials
Tony CastlemanInternational Food Aid Conference
April 15, 2008
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Outline
1. Background
2. CSB vs. RUFS for Adult ART Clients in Malawi
3. FBF vs. No Food for HIV+ Adults in Kenya
4. CSB vs. milk-peanut RUTF vs. soy-peanut RUTF for children with moderate acute malnutrition in Malawi
5. Conclusions and Future Directions
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Background: Food and HIV
• Strong evidence on association between PLHIV nutritional status and mortality.
• Much less evidence on impacts of nutrition interventions for PLHIV.
• ART itself improves nutritional status but can also create additional nutrition issues.
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Background: Specialized Food Products
• Fortified blended foods (FBF)– CSB has a long history of use in a range of
programs with various objectives
– In many settings it is a more nutritious form of commonly used staple foods
– Questions have been raised about its effectiveness in addressing malnutrition
– Efforts to improve CSB have begun
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Background: Specialized Food Products
• Ready-to-use foods– Ready-to-use therapeutic food (RUTF) was
developed – and is very effective – for children with severe acute malnutrition
– Recent expansion to other populations: HIV+ adults, moderately malnourished children
– May not be optimal food for all groups; adaptations and alternative formulations are underway
– RUFs are relatively expensive, and cost-effectiveness is a consideration
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CSB vs. RUFS for Adult ART Clients: Research Question
For malnourished adults starting ART, does food supplementation with ready-to-use fortified spread (RUFS) improve nutritional and clinical status more than food supplementation with CSB does?
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CSB vs. RUFS for Adult ART Clients:Design
• Randomized, investigator-blinded effectiveness trial.
• Implemented at Queen Elizabeth Hospital, Malawi by Washington Univ. at St. Louis (Mark Manary, PI).
• Non-pregnant adults starting ART with BMI < 18.5 kg/m2 (average 16.5 kg/m2).
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374 g./day CSB (1,360 kcal/day) for 3.5 months
n=246
Enrollment
n=491
Randomization
CSB vs. RUFS for Adult ART Clients:Design
260 g./day RUFS (1,360 kcal/day) for 3.5 months
n=245
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CSB vs. RUFS for Adult ART Clients: Results
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CSB vs. RUFS for Adult ART Clients: Results
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CSB vs. RUFS: Results
After 3.5 months of supplementation
- Above differences were statistically significant.- Differences in CD4, survival, QOL, adherence were not significant.- At 3, 6, 9 months after food ended, there were no significant differences in any outcomes.- RUFS is approx. 3X the cost of CSB.
Weight Gain Fat-Free Mass Gain
CSB 4.3 kg 2.2 kg
RUFS 5.6 kg 2.9 kg
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CSB vs. RUFS for Adult ART Clients: Results
• Subjects included mild, moderate, and severely malnourished. Difference between RUFS and CSB may be greater among severely malnourished.
• High case fatality rate– 27% after 3.5 months of food– 43% after 12.5 months (3.5 food + 9 follow-up)
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FBF vs. No Food for HIV+ Adults: Research Question
Does food supplementation of malnourished HIV-infected adult ART and pre-ART clients improve nutritional status, clinical outcomes, and drug adherence?
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FBF vs. No Food for HIV+ Adults: Design
• Randomized effectiveness trial.
• Implemented at 6 HIV treatment sites in Kenya by Kenya Medical Research Institute (KEMRI) .
• Non-pregnant ART adult clients with BMI < 18.5 kg/m2.
• Pre-ART adults clients taking cotrimoxazole with BMI < 18.5, or 18.5-20 with weight loss.
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FBF vs. No Food for HIV+ Adults: Design
6 months of 1,320 kcal/day fortified blended food (corn, soy, oil sugar, whey concentrate, MN) + nutrition counseling
OR nutrition
counseling alone
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Nutrition counseling
n=~315
ART Enrollment
n=~630
Randomization
FBF vs. No Food for HIV+ Adults: Design
300 g./day FBF +
counseling
n=~315
Nutrition counseling
n=~210
pre-ART Enrollment
n=~420
Randomization
300 g./day FBF +
counseling
n=~210
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CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children:
Research Question
How do CSB, milk-peanut RUTF, and soy-peanut RUTF compare in helping children recover from moderate acute malnutrition?
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CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children:
Design
• Randomized effectiveness trial.
• Children aged 12-59 months with -3 < WHZ < -2.
• 8 weeks of CSB or peanut-milk RUTF or soy-peanut RUTF.
• Implemented at 7 supplementary feeding sites in Malawi by Washington Univ. at St. Louis (Mark Manary, PI).
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75 kcal/kg/day CSB
n=~450
Enrollment
n=~1,350
Randomization
CSB vs. milk-RUTF vs. soy-RUTF: Design
75 kcal/kg/day soy-peanut
RUTF
n=~450
75 kcal/kg/day milk-peanut
RUTF
n=~450
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CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children:
Preliminary Results
• All groups had good recovery rates, with RUTF groups somewhat better
• Milk-peanut RUTF is 4X the cost of CSB and soy-peanut RUTF is 2X the cost of CSB
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Conclusions & Future Directions
• Need to balance effectiveness and cost-effectiveness.
• Program settings may matter in identifying most effective (and cost-effective) food products for a given target population, e.g. clinical vs. community setting.
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Conclusions & Future Directions
• Reports of CSB’s demise may be exaggerated: FBF products can help achieve nutrition objectives for some target groups.
• Need to adapt and enhance formulations of both types of products for specific target groups and objectives.
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(RUSF; RUFS; use soy instead of milk)
Conclusions & Future Directions
(enhanced FBFs)