TABLE 2.
Summary of trials on the role of micronutrients and HIV progression in adults1
| Effect on |
|||||||
| First author (reference),country (year) | Study population(no. receiving HAART)2 | Nutritional intervention | Control group | CD4 count | Viral load | Progression and/or survival | Other outcomes |
| Low-income settings | |||||||
| Kelly (38), Zambia (2008) | 276 HIV+ and 224 HIV− patients (26) | Combination of 15 micronutrients for 1.9 y then crossover until 3.4 y (crossover trial) | Placebo | No significant effect | Not reported | Decreased Mortality | Significantly reduced severity of diarrhea but no significant difference in incidence of diarrhea, respiratory illness, or nutritional indexes |
| Kupka (40), Tanzania (2008) | 913 pregnant HIV+ women (31) | Selenium + prenatal iron, folic acid, and vitamins from enrollment to 6 mo postpartum | Placebo + prenatal iron, folic acid and vitamins | No significant effect | No significant effect | No significant effect | Significantly reduced risk of child mortality after 6 wk but no significant effect on LBW, fetal death, or other infant outcomes |
| Villamor (43), Tanzania (2008) | 471 HIV+ and 416 HIV− patients with tuberculosis (0) | Combination of 10 micronutrients for median follow-up of 30 mo in HIV+ patients and 52 mo in HIV− patients | Placebo | No significant effect | No significant effect | No significant effect on mortality overall but marginally decreased mortality in HIV-negative | Significantly reduced incidence of peripheral neuropathy regardless of HIV status |
| Villamor (42), Tanzania (2006) | 400 pregnant HIV+ women (0) | Zinc + vitamins B-1 (thiamine), B-2 (riboflavin), B-3, B-6, B-12, C, and E; antenatal iron and folate from first antenatal visit to 6 wk postpartum | Vitamins B-1, B-2, B-3, B-6, B-12, C, and E; antenatal iron and folate | Not Reported | No significant effect | Not Reported | Significantly increased risk of wasting (MUAC <22 cm) but no significant effect on MTCT or other anthropometric indexes |
| de Souza Jr (44), Brazil (2005) | 29 HIV+ patients (26) | α-Tocopherol for 180 d | Placebo | No significant effect | No significant effect | Not reported | Significantly improved lymphocyte viability |
| Fawzi (37), Tanzania (2004) | 1078 pregnant HIV+ women (0) | Factorial design: 1) vitamin A alone; 2) vitamins B-1, B-2, B-3, B-6, B-12, C, and E; 3) both 1) and 2); all received antenatal iron and folate | Placebo + antenatal iron and folate | Increased in non–vitamin A group | Decreased in non–vitamin A group | Decreased progression/ improved survival (composite) in non–vitamin A group | Significantly reduced incidence of oral ulcers, cheilitis, difficulty swallowing, dysentery, and fatigue. No significant effect on diarrhea. |
| McClelland (41), Kenya (2004) | 400 HIV+ women (0) | Combination of 9 micronutrients for 6 wk | Placebo | No significant effect | No significant effect | Not reported | Significantly higher vaginal HIV shedding |
| Jiamton (46), Thailand (2003) | 481 HIV+ patients (10) | Combination of 21 micronutrients for 48 wk | Placebo | No significant effect | No significant effect | Improved survival in patients with CD4 counts <200 | No significant difference in hospitalization |
| Spada (45), Brazil (2002) | 18 HIV+ patients (18) | α-Tocopherol for 60 d + HAART | Placebo + HAART | No significant effect | No significant effect | Not reported | None |
| Kelly (39), Zambia (1999) | 135 HIV+ patients with persistent diarrhea (Unknown) | Combination of 5 micronutrients + 800 mg twice-daily albendazole for 14 d | Placebo + 800 mg twice-daily albendazole | No significant effect | Not reported | No significant effect | No significant difference in diarrhea outcomes |
| High-income settings | |||||||
| Baum (29), United States (2010) | 231 Zinc deficient HIV+ patients (144) | Elemental zinc for 18 mo | Placebo | Prevented immunologic failure | No significant effect | No significant effect | Significantly reduced diarrhea but no significant differences in upper or lower respiratory disease |
| Hurwitz (34), United States (2007) | 310 HIV+ patients (240) | High-selenium yeast for 9 mo | Placebo | Increased (used modeling) | Decreased (used modeling) | Not reported | None |
| Austin (28), Canada (2006) | 331 HIV+ patients (259) | Natural mixed carotenoids + 28 micronutrients for median follow-up of 13 mo | 28 micronutrients only | No significant effect | No significant effect | No significant effect | None |
| Kaiser (35), United States (2006) | 40 HIV+ patients (40) | Combination of 33 micronutrients for 12 wk | Placebo | Increased | No significant effect | Not reported | No significant effect on peripheral neuropathy or metabolic indexes |
| Burbano (30), United States (2002) | 186 HIV+ patients (85) | Selenium for 2 y | Placebo | Increased | Not reported | Not reported | Significantly decreased hospitalization rates, frequency, and costs but no significant effect on duration |
| Jaruga (47), Poland (2002) | 30 HIV+ patients (30) | Vitamins A, E, and C for 6 mo | Placebo | No significant effect | Not reported | Not reported | Significantly reduced oxidant stress |
| Batterham (48), Australia (2001) | 66 HIV+ patients (50) | Combination of 11 micronutrients, milk thistle, and grapeseed for 12 wk at a higher dose than control group (nonrandomized) | Combination of 11 micronutrients, milk thistle, and grapeseed at a lower dose than study group | Not reported | No significant effect | Not reported | No significant effect on oxidant stress markers |
| Humphrey (33), United States (1999) | 40 HIV+ women (0) | Single dose of vitamin A | Placebo | Increased | No significant effect | Not reported | No significant difference in lymphocyte proliferation response to PHA or candida |
| Allard (27), Canada (1998) | 49 HIV+ patients (unknown) | α-Tocopherol and vitamin C for 3 mo | Placebo | Not reported | No significant effect | No significant effect on new OIs | Significantly reduced oxidant stress (lipid peroxidation) |
| Semba (36), United States (1998) | 120 HIV+ patients (0) | Single dose of vitamin A for a follow-up of 4 wk | Placebo | No significant effect | No significant effect | Not reported | None |
| Coodley (31), United States (1996) | 72 HIV+ patients (unknown) | β-Carotene + multivitamin supplement for 3 mo | Placebo + multivitamin supplement | No significant effect | Not reported | Not reported | No significant difference in NK cells or p24 antigen |
| Coodley (32), United States (1993) | 21 HIV+ patients (0) | β-Carotene for 4 wk (crossover trial) | Placebo | No significant effect | Not reported | Not reported | Significant increase in white blood cell count |
1
Results compared the intervention group with control groups; changes within group over time are not reported. HAART, highly active anti-retroviral therapy; LBW, low birth weight; MTCT, mother-to-child transmission; MUAC, mid–upper arm circumference; NK, natural killer; PHA, phytohemagglutinin,
2
Single-drug and 2-drug combinations not included in our definition of HAART; status reported as unknown if sufficient details of regimens were not provided to confirm definition of HAART.