105 research outputs found

    Letters to the editor

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    Vitamins and Perinatal Outcomes Among HIV-Negative Women in Tanzania.

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    Prematurity and low birth weight are associated with high perinatal and infant mortality, especially in developing countries. Maternal micronutrient deficiencies may contribute to these adverse outcomes. In a double-blind trial in Dar es Salaam, Tanzania, we randomly assigned 8468 pregnant women (gestational age of fetus, 12 to 27 weeks) who were negative for human immunodeficiency virus infection to receive daily multivitamins (including multiples of the recommended dietary allowance) or placebo. All the women received prenatal supplemental iron and folic acid. The primary outcomes were low birth weight (<2500 g), prematurity, and fetal death. The incidence of low birth weight was 7.8% among the infants in the multivitamin group and 9.4% among those in the placebo group (relative risk, 0.82; 95% confidence interval [CI], 0.70 to 0.95; P=0.01). The mean difference in birth weight between the groups was modest (67 g, P<0.001). The rates of prematurity were 16.9% in the multivitamin group and 16.7% in the placebo group (relative risk, 1.01; 95% CI, 0.91 to 1.11; P=0.87), and the rates of fetal death were 4.3% and 5.0%, respectively (relative risk, 0.87; 95% CI, 0.72 to 1.05; P=0.15). Supplementation reduced both the risk of a birth size that was small for gestational age (<10th percentile; 10.7% in the multivitamin group vs. 13.6% in the placebo group; relative risk, 0.77; 95% CI, 0.68 to 0.87; P<0.001) and the risk of maternal anemia (hemoglobin level, <11 g per deciliter; relative risk, 0.88; 95% CI, 0.80 to 0.97; P=0.01), although the difference in the mean hemoglobin levels between the groups was small (0.2 g per deciliter, P<0.001). Multivitamin supplementation reduced the incidence of low birth weight and small-for-gestational-age births but had no significant effects on prematurity or fetal death. Multivitamins should be considered for all pregnant women in developing countries. (ClinicalTrials.gov number, NCT00197548 [ClinicalTrials.gov].)

    Lipid-soluble Vitamins A, D, and E in HIV-Infected Pregnant women in Tanzania.

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    There is limited published research examining lipid-soluble vitamins in human immunodeficiency virus (HIV)-infected pregnant women, particularly in resource-limited settings. This is an observational analysis of 1078 HIV-infected pregnant women enrolled in a trial of vitamin supplementation in Tanzania. Baseline data on sociodemographic and anthropometric characteristics, clinical signs and symptoms, and laboratory parameters were used to identify correlates of low plasma vitamin A (<0.7 micromol/l), vitamin D (<80 nmol/l) and vitamin E (<9.7 micromol/l) status. Binomial regression was used to estimate risk ratios and 95% confidence intervals. Approximately 35, 39 and 51% of the women had low levels of vitamins A, D and E, respectively. Severe anemia (hemoglobin <85 g/l; P<0.01), plasma vitamin E (P=0.02), selenium (P=0.01) and vitamin D (P=0.02) concentrations were significant correlates of low vitamin A status in multivariate models. Erythrocyte Sedimentation Rate (ESR) was independently related to low vitamin A status in a nonlinear manner (P=0.01). The correlates of low vitamin D status were CD8 cell count (P=0.01), high ESR (ESR >81 mm/h; P<0.01), gestational age at enrollment (nonlinear; P=0.03) and plasma vitamins A (P=0.02) and E (P=0.01). For low vitamin E status, the correlates were money spent on food per household per day (P<0.01), plasma vitamin A concentration (nonlinear; P<0.01) and a gestational age <16 weeks at enrollment (P<0.01). Low concentrations of lipid-soluble vitamins are widely prevalent among HIV-infected women in Tanzania and are correlated with other nutritional insufficiencies. Identifying HIV-infected persons at greater risk of poor nutritional status and infections may help inform design and implementation of appropriate interventions

    Int J STD AIDS

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    To determine the prevalence and predictors of cervical squamous intraepithelial lesions (SIL) among HIV-infected women in Tanzania, a cross-sectional study was conducted among HIV-infected women at HIV care and treatment clinics. A Papanicolaou (Pap) smear was used as a screening tool for detection of cervical SIL. From December 2006 to August 2009, 1365 HIV-infected women received cervical screening. The median age was 35 (interquartile range [IQR]: 30-42) years, and the median CD4\u2009+\u2009cell count was 164 (IQR: 80-257) cells/mm(3). The prevalence of cervical SIL was 8.7% (119/1365). In multivariate analysis, older age ( 6550 versus 30-<40 years: prevalence ratio [PR], 2.36; 95% confidence interval [CI], 1.45-3.84, p for trend\u2009=\u20090.001), lower CD4\u2009+\u2009cell counts (<100 versus 65200\u2009cells/mm(3): PR, 1.55; 95% CI, 1.01-2.36, p for trend\u2009=\u20090.03) and cervical inflammation (PR, 1.73; 95% CI, 1.16-2.60, p\u2009=\u20090.008) were associated with an increased risk of cervical SIL. Women with advanced WHO HIV disease stage (IV versus I/II: PR, 3.45; 95% CI, 1.35-8.85, p for trend\u2009=\u20090.01) had an increased risk for high-grade SIL. In resource-limited settings where it is not feasible to provide cervical cancer prevention services to all HIV-infected women, greater efforts should focus on scaling-up services among those who are older than 50 years, with lower CD4 cell counts and advanced HIV disease stage.P30 MH062294/MH/NIMH NIH HHSUnited States/U2G PS001966/PS/NCHHSTP CDC HHSUnited States

    AIDS

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    ObjectiveTo determine the incidence rate and risk factors of tuberculosis (TB) among HIV-infected adults accessing antiretroviral therapy (ART) in Tanzania.DesignA prospective observational study among HIV-infected adults attending 47 HIV clinics in Dar es Salaam.MethodsWe estimated TB incidence rates among HIV-infected patients prior to and after ART initiation. We used Cox proportional hazard regressions to determine the predictors of incident TB among HIV-infected adults enrolled in the HIV care and treatment program.ResultsWe assessed 67,686 patients for a median follow-up period of 24 (interquartile range: 8\u201349) months; 7,602 patients were diagnosed with active TB. The TB incidence rate was 7.9 (95% Confidence Interval (CI), 7.6\u20138.2)/100 person-years prior to ART initiation, and 4.4(95%CI, 4.2\u20134.4)/100 person-years for patients receiving ART. In multivariate analyses, patients on ART in the first 3 months had a 57% higher risk of TB (Hazard Ratio:1.57, 95%CI:1.47\u20131.68) compared to those not on ART, but the risk significantly decreased with increasing duration of ART. Risk factors for incident TB included being male, having low body mass index or middle upper arm circumference, lower CD4 cell count, and advanced WHO disease stage. There was seasonal variation for incident TB, with higher risk observed following the rainy seasons (May, June, and November).ConclusionIn TB endemic regions, HIV-infected patients initiating ART, particularly males and those with poor nutritional status, should be closely monitored for active TB in the months following ART initiation. In addition to increasing the access to ART, interventions should be considered to improve nutritional status among HIV-infected patients.20152015-09-21T00:00:00Z5U2GPS001966/PHS HHS/United StatesU2G PS001966/PS/NCHHSTP CDC HHS/United States26091295PMC4576970672

    Contemp Clin Trials Commun

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    IntroductionResearchers planning cluster-randomized controlled trials (cRCTs) require estimates of the intra-cluster correlation coefficient (ICC) from previous studies for sample size calculations. This paper fills a persistent gap in the literature by providing estimates of ICCs for many key HIV-related clinical outcomes.MethodsData from HIV-positive patients from 47 HIV care and treatment clinics in Dar es Salaam, Tanzania were used to calculate ICCs by site of enrollment or site of ART initiation for various clinical outcomes using cross-sectional and longitudinal data. ICCs were estimated using linear mixed models where either clinic of enrollment or clinic of ART initiation served as the random effect.ResultsICCs ranged from 0 to 0.0706 (95% CI: 0.0447, 0.1098). For most outcomes, the ICCs were large enough to meaningfully affect sample size calculations. For binary outcomes, the ICCs for event prevalence at baseline tended to be larger than the ICCs for later cumulative incidences. For continuous outcomes, the ICCs for baseline values tended to be larger than the ICCs for the change in values from baseline.ConclusionThe ICCs for HIV-related outcomes cannot be ignored when calculating sample sizes for future cluster-randomized trials. The differences between ICCs calculated from baseline data alone and ICCs calculated using longitudinal data demonstrate the importance of selecting an ICC that reflects a study\u2019s intended design and duration for sample size calculations. While not generalizable to all contexts, these estimates provide guidance for future researchers seeking to design adequately powered cRCTs in Sub-Saharan African HIV treatment and care clinics.DP1 ES025459/ES/NIEHS NIH HHSUnited States/R01 AI112339/AI/NIAID NIH HHSUnited States/U2G PS001966/PS/NCHHSTP CDC HHSUnited States

    AIDS

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    Objective:The objective of this study was to assess the effectiveness of a routine multivitamin supplementation program for adults living with HIV in Tanzania.Design:We conducted a retrospective cohort study of 67,707 adults enrolled in the Dar es Salaam HIV care and treatment program during 2004\u20132012.Methods:The Dar es Salaam HIV care and treatment program intended to provide all adult patients with multivitamin supplements (vitamins B-complex, C, and E) free of charge; however, intermittent stockouts and other implementation issues did not afford universal coverage. We use Cox proportional hazard models to assess the time-varying association of multivitamin supplementation with mortality and clinical outcomes.Results:The study cohort contributed 41,540 and 129,315 person-years of follow-up time to the ART-na\uefve and ART-experienced analyses, respectively. Among 48,207 ART-na\uefve adults, provision of multivitamins reduced the risk of mortality (adjusted hazard ratio (aHR): 0.69; 95% CI: 0.59\u20130.81), incident tuberculosis (TB) (aHR: 0.83; 0.76\u20130.91), and meeting ART eligibility criteria (aHR: 0.78; 95% CI: 0.73\u20130.83) after adjustment for time-varying confounding. Among 46,977 ART-experienced patients, multivitamins reduced mortality (HR: 0.86; 95% CI: 0.80\u20130.92), incident TB (aHR: 0.78; 95% CI: 0.73\u20130.84), and immunologic failure (aHR: 0.70; 95% CI: 0.67\u20130.73). The survival benefits associated with provision multivitamins appeared to be greatest during the first year of ART and declined over time (p-value <0.001).Conclusion:Multivitamin supplementation appears to be a simple, effective, safe, and scalable program to improve survival, reduce incidence of TB, and improve treatment outcomes for adult HIV patients in Tanzania.20192020-01-27T00:00:00ZD43 TW009775/TW/FIC NIH HHS/United StatesU2G PS001966/PS/NCHHSTP CDC HHS/United StatesPEPFAR/PEPFAR/United States30289815PMC6599688712

    Supplementation with vitamin A reduces watery diarrhoea and respiratory infections in Mexican children

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    Previous clinical vitamin A trials have found no consistent effect on diarrhoeal disease and respiratory tract infection. These inconsistent results may be due to the distinct effects vitamin A supplementation has among children stratified by factors related to socio-economic status, nutritional status and season. We evaluated the effect of supplementation on the overall incidence of diarrhoeal disease and respiratory tract infections and on the incidence among children stratified by these factors. A total of 188 children, aged 6–15 months, from periurban, marginalized communities of Mexico City were assigned to receive vitamin A ( < 12 months of age, 20 000 IU retinol; ≥ 12 months, 45 000 IU retinol) or a placebo every 2 months, and were followed for up to 15 months. Project personnel visited households twice a week to determine the onset and duration of diarrhoeal disease and respiratory tract infections. Vitamin A supplementation had no significant effect on risk of overall diarrhoeal disease but reduced mild watery diarrhoea (incidence rate ratio (RR) 0·69; 95 % CI 0·50, 0·93) and cough with fever (RR 0·69; 95 % CI 0·48, 0·98). Vitamin A supplementation decreased diarrhoeal disease during the summer (RR 0·74; 95 % CI 0·57, 0·94), among non-stunted children (RR 0·69; 95 % CI 0·52, 0·93) and among children from households with better socio-economic measures. Heterogeneity in the response to vitamin A supplementation may reflect heterogeneity in the aetiology and epidemiology of diarrhoeal disease and respiratory tract infections and the impact that supplementation has on the immune response

    Effect of Selenium Supplements on Hemoglobin Concentration and Morbidity Among HIV-1-Infected Tanzanian Women.

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    Selenium deficiency may increase risks of anemia and morbidity among people with human immunodeficiency virus infection. We therefore investigated the effect of selenium supplements (200 microg of selenomethionine) on these end points among 915 pregnant Tanzanian women. Hemoglobin concentration was measured at baseline (at 12-27 weeks of gestation) and at 6 weeks and 6 months postpartum, and morbidity data were collected during monthly visits to the clinic. Selenium supplements had no effect on hemoglobin concentrations during follow-up (mean difference, 0.05 g/dL; 95% confidence interval, -0.07 to 0.16 g/dL) but reduced diarrheal morbidity risk by 40% (relative risk, 0.60; 95% confidence interval, 0.42-0.84). There was no effect on the other morbidity end points
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