Randomised trial of food supplementation in food insecure patients ART inconclusive

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Although patients on antiretroviral therapy who receive food supplementation experience weight gain and show better adherence to treatment than those who receive antiretrovirals alone, researchers on a large randomised study in Zambia found no significant effect on long-term treatment response, Dr Karen Megazzini of the University of Alabama reported on Monday at the Sixteenth International AIDS Conference in Toronto, Canada.

Food insecurity (persistent hunger) is widespread among HIV-positive people in sub-Saharan Africa, and food insecurity increases both the risk of HIV infection and disease progression, according to Care International, a non-governmental organization that works on poverty reduction.

Care International highlighted the links between food insecurity, poverty and HIV today at the conference, calling for governments to implement recent international declarations on the need to integrate food security programmes into HIV efforts.

Glossary

pilot study

Small-scale, preliminary study, conducted to evaluate feasibility, time, cost, adverse events, and improve upon the design of a future full-scale research project.

 

haemoglobin (HB)

Red-coloured, oxygen-carrying chemical in red blood cells.

disease progression

The worsening of a disease.

body mass index (BMI)

Body mass index, or BMI, is a measure of body size. It combines a person's weight with their height. The BMI gives an idea of whether a person has the correct weight for their height. Below 18.5 is considered underweight; between 18.5 and 25 is normal; between 25 and 30 is overweight; and over 30 is obese. Many BMI calculators can be found on the internet.

WHO stage

A simplified system to describe four clinical stages of HIV-related disease, based on clinical parameters (symptoms, weight loss and different opportunistic infections) rather than decreasing CD4 cell count. Stage I is asymptomatic, stage II mild symptoms, stage III advanced symptoms and stage IV severe symptoms (an AIDS diagnosis).

However, the impact of food supplementation in food insecure populations on the clinical outcome of, and adherence to ART, is not known. Researchers from the Center for Infectious Disease Research in Lusaka, Zambia set out to investigate its effects in a home-based adherence program based in eight government clinics in Lusaka, Zambia.

The investigators randomly assigned four clinics to provide a monthly ration of corn-soya blend fortified with micronutrients in a food-insecure population starting ART (375 food recipients); the remaining four clinics did not provide supplementation and served as controls (161 non-food recipients). Changes in weight and CD4 counts were measured at six months and twelve months. Adherence was measured as the timeliness of pharmacy visits.

Patients were defined as food insecure if they had a monthly income of less than $40 a month as the primary earner in the household and/or if they had purchased less than 5kg of maize meal in the previous month, or if they were skipping meals every other day on average.

The participants in the food supplementation arm were provided with a corn/soya blend ration of 200g a day for themselves, and if they were the primary earner, a similar amount for up to six household members. They also received 20ml of oil per day, and the household received a ration of beans and maize. Seventy-six per cent of participants received rations both for themselves and for their household. Fifty-eight per cent of participants were women.

At the beginning of the study (baseline), food recipients and non-food recipients were comparable in age, BMI, CD4 count, WHO stage, hemoglobin, and gender distribution.

For food recipients, the median number of rations received was nine and the median time between starting ART and first ration was 64 days.

There was a significant difference in weight gain (kilograms) at six ( +5.4 vs + 3.9 kg; p = 0.05) and twelve months (+6.6 vs +3.8; p = 0.003) between food recipients and non-food recipients. Food recipients also had a significantly lower mean number of days late for pharmacy visits per month than non-food recipients (+ 2.4 vs +3.3; p = 0.009).

However food recipients did not have a significantly greater increase in CD4 counts at 12 months than non-food recipients (+ 185 vs +132; p = 0.17).

In this pilot study, a monthly household food ration for food insecure patients commencing ART improved adherence by 40 % and resulted in weight gain, but the investigators say that additional studies are needed to validate the usefulness of food supplementation as a complement to ART in food insecure patients.

References

Megazzini K et al. A pilot randomized trial of nutritional supplementation in food insecure patients receiving antiretroviral therapy in Zambia. Sixteenth International AIDS Conference in Toronto, Canada, abstract MoAb0401, 2006.