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Title: Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: Randomised, Investigator Blinded, Controlled Trial

Author
item NDEKHA, MACDONALD - University Of Malawi
item VAN OOSTERHOUT, JOEP - University Of Malawi
item ZIJLSTRA, EDUARD - University Of Malawi
item MANARY, MICAH - Washington University School Of Medicine
item SALOOJEE, HAROON - University Of The Witswatersrand
item MANARY, MARK - Washington University School Of Medicine

Submitted to: British Medical Journal
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/19/2009
Publication Date: 5/22/2009
Citation: Ndekha, M.J., Van Oosterhout, J.J.G., Zijlstra, E.E., Manary, M., Saloojee, H., Manary, M.J. 2009. Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: Randomised, Investigator Blinded, Controlled Trial. British Medical Journal. 338:b1867.

Interpretive Summary: Supplementary feeding in conjunction with treatment is the standard of care for HIV-positive adults receiving therapy in Malawi, Africa. The most common supplementary food in food aid programs is inexpensive, readily available corn-soy blended flour but the flour must be cooked. A fortified spread, which contains the same nutrients as milk-based therapeutic food, has been associated with better outcomes in treating malnourished children with, and without HIV, has been developed. A feeding trial tested the hypothesis that among HIV-positive adults starting antiretroviral therapy, patients who receive the fortified spread for 14 weeks will have a greater increase in BMI and fat-free body mass than those receiving corn-soy blends. Participants receiving the fortified spread gained more BMI than those receiving corn-soy blends. This suggests that the fortified spread was superior to corn-soy blend throughout the study. These findings are important for nourishment of malnourished populations however, the long-term benefits of the supplementary food need to be further evaluated.

Technical Abstract: To investigate the effect of two different food supplements on body mass index (BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy. A randomised, investigator blinded, controlled trial was used in a large, public clinic associated with a referral hospital in Blantyre, Malawi. Our participants included 491 adults with BMI <18.5. Ready-to-use fortified spread (n=245) or corn-soy blend (n=246) was used in the intervention. The primary outcomes were changes in BMI and fat-free body mass after 3.5 months with our secondary outcomes being survival, CD4 count, HIV viral load, quality of life, and adherence to antiretroviral therapy. The mean BMI at enrolment was 16.5. After 14 weeks, patients receiving fortified spread had a greater increase in BMI and fat-free body mass than those receiving corn-soy blend: 2.2 (SD 1.9) v 1.7 (SD 1.6) (difference 0.5, 95% confidence interval 0.2 to 0.8), and 2.9 (SD 3.2) v 2.2 (SD 3.0) kg (difference 0.7 kg, 0.2 to 1.2 kg), respectively. The mortality rate was 27% for those receiving fortified spread and 26% for those receiving corn-soy blend. No significant differences in the CD4 count, HIV viral load, assessment of quality of life, or adherence to antiretroviral therapy were noted between the two groups. Supplementary feeding with fortified spread resulted in a greater increase in BMI and lean body mass than feeding with corn-soy blend.