Nutritional Supplements Can Delay the Progression of AIDS in HIV-Infected Patients : Results from a Double-Blinded , Clinical Trial at Mengo Hospital , Kampala , Uganda

Abstract Objective: To examine the immunologic, biochemical and clinical effects of two combinations of nutritional supplements on the progression to AIDS of HIV-infected patients not receiving anti-retroviral treatment. Design: A prospective randomized, double-blinded clinical trial. Methods: 249 female and 61 male HIVinfected outpatients of Mengo Hospital, Kampala, Uganda, with baseline CD4 cell counts above 200, who were not receiving anti-retroviral drugs, were randomized into Groups A and B. Group A patients received capsules containing 37 nutrients, while those in Group B were given capsules of 30 nutrients. Both nutritional combinations were designed to increase glutathione peroxidase levels. All patients were instructed to take two capsules, three times daily with meals for 52 weeks. 310 patients began the year long study and 263 completed it. The loss to follow-up, therefore, was some 15.2 percent. Serum glutathione peroxidase levels and CD4 cell counts were measured at baseline, after 28 weeks and at the trial’s end which was 52 weeks after patients began taking nutrients. Patient weights were recorded at six weekly intervals. Karnofsky scores were used to establish changes in the quality of life and were measured at the beginning of the trial and at 30 and 52 weeks. The study examined the effects of these two combinations of nutrients on biochemical and immunologic parameters, that is, serum glutathione peroxidase levels and CD4 cell counts as the study’s primary endpoint. Secondary end points were weight changes and patient assessed quality of life. Results: The mean/median serum glutathione peroxidase levels in Group A (37 nutrients) increased from 3825/3628 U/L (International Units) at baseline to 8894/8575 U/L at the trial’s end (p<0.000). Similarly, patients in Group B (30 nutrients) had an increase in mean/median serum glutathione peroxidase levels from 3862/3602 to 9839/9203 U/L over the length of the trial (p<0.000). The mean/median CD4 cell counts rose from 400/347 mm to 446/388 in Group A and from 400/335 to 446/394 mm in Group B (p<0.000). Mean weight increases over 52 weeks were 1.0 kg in Group A and 1.4 kg in Group B, while Karnofsky scores in Group A rose from 81 to 85 and in Group B from 82 to 86. Wilcoxan Signed Ranks Test and the Sign Test both indicated that all these measured increases within both groups were statistically significant (p<0.01). Indeed, for both glutathione peroxidase levels and CD4 cell counts p<0.000 in all cases. There were, however, no statistically significant differences between the measured parameters, (serum glutathione peroxidase, CD4 cell counts, weight and Karnofsky scores) in Group A compared with those of Group B (p>0.05), or between Nutritional Supplements Can Delay the Progression of AIDS in HIV-Infected Patients: Results from a Double-Blinded, Clinical Trial at Mengo Hospital, Kampala, Uganda