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.

Objective: 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.
Design: Randomised, investigator blinded, controlled trial.
Setting: Large, public clinic associated with a referral hospital in Blantyre, Malawi.
Participants: 491 adults with BMI <18.5.
Interventions: Ready-to-use fortified spread (n=245) or corn-soy blend (n=246).
Primary Outcomes: changes in BMI and fat-free body mass after 3.5 months.
Secondary Outcomes: survival, CD4 count, HIV viral load, quality of life, and adherence to antiretroviral therapy.
Results: 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.
Conclusion: Supplementary feeding with fortified spread resulted in a greater increase in BMI and lean body mass than feeding with corn-soy blend.
Trial Registration: Current Controlled Trials ISRCTN67515515.