OBJECTIVES: To assess the immuno-clinical response of micronutrients supplementation in human immunodeficiency virus (HIV) infected children (both on and without antiretroviral therapy) and to assess the role of probiotics in improvement of CD4 counts in HIV infected children not on antiretroviral therapy. METHODS: This was an open labeled randomized control study, conducted in Department of Pediatrics and Antiretrovial Therapy (ART) Center, S.N. Medical College, Agra. One hundred and twenty seven HIV infected children aged ≤ 15 y were included in the study. Enrolled children were randomized to receive micronutrients for 6 mo or probiotics for 3 mo. Children who did not receive supplements served as control. Change in WHO clinical stage, immunological stage, CD4 counts and body mass index (BMI) status were taken at the end of 6 mo. In probiotic group, mean CD4 count were taken as outcome measure. A detailed history, examination and WHO clinical staging were recorded for all the patients. RESULTS: In micronutrient supplemented group (not on ART), significant improvement was seen in WHO clinical staging (p = 0.049) when compared to controls after 6 mo. Probiotic supplemented group showed significant increase in CD4 counts compared to control group (p = 0.0022) in children >5 y. Control group showed significant decline in CD4 count in children≤5 y (-65.3 cells/mm(3), p=0.005) and in children >5 y (-87.9 cells/mm(3), p=0.05) after 12 wk of supplementation. CONCLUSIONS:Probiotics supplementation has shown significant improvement in CD4 counts. Micronutrients supplementation has shown significant delay in the progression towards advance stage of disease.
RCT Entities:
OBJECTIVES: To assess the immuno-clinical response of micronutrients supplementation in human immunodeficiency virus (HIV) infectedchildren (both on and without antiretroviral therapy) and to assess the role of probiotics in improvement of CD4 counts in HIV infectedchildren not on antiretroviral therapy. METHODS: This was an open labeled randomized control study, conducted in Department of Pediatrics and Antiretrovial Therapy (ART) Center, S.N. Medical College, Agra. One hundred and twenty seven HIV infectedchildren aged ≤ 15 y were included in the study. Enrolled children were randomized to receive micronutrients for 6 mo or probiotics for 3 mo. Children who did not receive supplements served as control. Change in WHO clinical stage, immunological stage, CD4 counts and body mass index (BMI) status were taken at the end of 6 mo. In probiotic group, mean CD4 count were taken as outcome measure. A detailed history, examination and WHO clinical staging were recorded for all the patients. RESULTS: In micronutrient supplemented group (not on ART), significant improvement was seen in WHO clinical staging (p = 0.049) when compared to controls after 6 mo. Probiotic supplemented group showed significant increase in CD4 counts compared to control group (p = 0.0022) in children >5 y. Control group showed significant decline in CD4 count in children ≤5 y (-65.3 cells/mm(3), p=0.005) and in children >5 y (-87.9 cells/mm(3), p=0.05) after 12 wk of supplementation. CONCLUSIONS: Probiotics supplementation has shown significant improvement in CD4 counts. Micronutrients supplementation has shown significant delay in the progression towards advance stage of disease.
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