Dataset Information

Effect of preventive supplementation with zinc and other micronutrients on non-malarial morbidity in Tanzanian pre-school children: a randomized trial.

ABSTRACT:

Background

The efficacy of preventive zinc supplementation against diarrhea and respiratory illness may depend on simultaneous supplementation with other micronutrients. We aimed to assess the effect of supplementation with zinc and multiple micronutrients on diarrhea and other causes of non-malarial morbidity.

Methods and findings

Rural Tanzanian children (n?=?612) aged 6-60 months and with height-for-age z-score < -1.5 SD were randomized to daily supplementation with zinc (10 mg) alone, multi-nutrients without zinc, multi-nutrients with zinc, or placebo. Children were followed for an average of 45 weeks. During follow-up, we recorded morbidity episodes. We found no evidence that concurrent supplementation with multi-nutrients influenced the magnitude of the effect of zinc on rates of diarrhea, respiratory illness, fever without localizing signs, or other illness (guardian-reported illness with symptoms involving skin, ears, eyes and abscesses, but excluding trauma or burns). Zinc supplementation reduced the hazard rate of diarrhea by 24% (4%-40%). By contrast, multi-nutrients seemed to increase this rate (HR; 95% CI: 1.19; 0.94-1.50), particularly in children with asymptomatic Giardia infection at baseline (2.03; 1.24-3.32). Zinc also protected against episodes of fever without localizing signs (0.75; 0.57-0.96), but we found no evidence that it reduced the overall number of clinic visits.

Conclusions

We found no evidence that the efficacy of zinc supplements in reducing diarrhea rates is enhanced by concurrent supplementation with other micronutrients. By reducing rates of fever without localizing signs, supplementation with zinc may reduce inappropriate drug use with anti-malarial medications and antibiotics.

Trial registration

ClinicalTrials.gov NCT00623857.

SUBMITTER: Veenemans J

PROVIDER: S-EPMC3411720 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of preventive supplementation with zinc and other micronutrients on non-malarial morbidity in Tanzanian pre-school children: a randomized trial.

Veenemans Jacobien J Schouten Laura R A LR Ottenhof Maarten J MJ Mank Theo G TG Uges Donald R A DR Mbugi Erasto V EV Demir Ayşe Y AY Kraaijenhagen Rob J RJ Savelkoul Huub F J HF Verhoef Hans H

PloS one 20120803 8

<h4>Background</h4>The efficacy of preventive zinc supplementation against diarrhea and respiratory illness may depend on simultaneous supplementation with other micronutrients. We aimed to assess the effect of supplementation with zinc and multiple micronutrients on diarrhea and other causes of non-malarial morbidity.<h4>Methods and findings</h4>Rural Tanzanian children (n = 612) aged 6-60 months and with height-for-age z-score < -1.5 SD were randomized to daily supplementation with zinc (10 mg ...[more]

PMID: 22870238

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Project description:It is uncertain to what extent oral supplementation with zinc can reduce episodes of malaria in endemic areas. Protection may depend on other nutrients. We measured the effect of supplementation with zinc and other nutrients on malaria rates.In a 2×2 factorial trial, 612 rural Tanzanian children aged 6-60 months in an area with intense malaria transmission and with height-for-age z-score?-1.5 SD were randomized to receive daily oral supplementation with either zinc alone (10 mg), multi-nutrients without zinc, multi-nutrients with zinc, or placebo. Intervention group was indicated by colour code, but neither participants, researchers, nor field staff knew who received what intervention. Those with Plasmodium infection at baseline were treated with artemether-lumefantrine. The primary outcome, an episode of malaria, was assessed among children reported sick at a primary care clinic, and pre-defined as current Plasmodium infection with an inflammatory response, shown by axillary temperature ?37.5°C or whole blood C-reactive protein concentration ? 8 mg/L. Nutritional indicators were assessed at baseline and at 251 days (median; 95% reference range: 191-296 days). In the primary intention-to-treat analysis, we adjusted for pre-specified baseline factors, using Cox regression models that accounted for multiple episodes per child. 592 children completed the study. The primary analysis included 1,572 malaria episodes during 526 child-years of observation (median follow-up: 331 days). Malaria incidence in groups receiving zinc, multi-nutrients without zinc, multi-nutrients with zinc and placebo was 2.89/child-year, 2.95/child-year, 3.26/child-year, and 2.87/child-year, respectively. There was no evidence that multi-nutrients influenced the effect of zinc (or vice versa). Neither zinc nor multi-nutrients influenced malaria rates (marginal analysis; adjusted HR, 95% CI: 1.04, 0.93-1.18 and 1.10, 0.97-1.24 respectively). The prevalence of zinc deficiency (plasma zinc concentration <9.9 µmol/L) was high at baseline (67% overall; 60% in those without inflammation) and strongly reduced by zinc supplementation.We found no evidence from this trial that zinc supplementation protected against malaria.ClinicalTrials.gov NCT00623857

Project description:BACKGROUND: Zinc deficiency is commonly prevalent in children in developing countries and plays a role in decreased immunity and increased risk of infection. Preventive zinc supplementation in healthy children can reduce mortality due to common causes like diarrhea, pneumonia and malaria. The main objective was to determine all-cause mortality and cause-specific mortality and morbidity in children under five in developing countries for preventive zinc supplementation. DATA SOURCES/ REVIEW METHODS: A literature search was carried out on PubMed, the Cochrane Library and the WHO regional databases to identify RCTs on zinc supplementation for greater than 3 months in children less than 5 years of age in developing countries and its effect on mortality was analyzed. RESULTS: The effect of preventive zinc supplementation on mortality was given in eight trials, while cause specific mortality data was given in five of these eight trials. Zinc supplementation alone was associated with a statistically insignificant 9% (RR = 0.91; 95% CI: 0.82, 1.01) reduction in all cause mortality in the intervention group as compared to controls using a random effect model. The impact on diarrhea-specific mortality of zinc alone was a non-significant 18% reduction (RR = 0.82; 95% CI: 0.64, 1.05) and 15% for pneumonia-specific mortality (RR = 0.85; 95% CI: 0.65, 1.11). The incidence of diarrhea showed a 13% reduction with preventive zinc supplementation (RR = 0.87; 95% CI: 0.81, 0.94) and a 19% reduction in pneumonia morbidity (RR = 0.81; 95% CI: 0.73, 0.90). Keeping in mind the direction of effect of zinc supplementation in reducing diarrhea and pneumonia related morbidity and mortality; we considered all the outcomes for selection of effectiveness estimate for inclusion in the LiST model. After application of the CHERG rules with consideration to quality of evidence and rule # 6, we used the most conservative estimates as a surrogate for mortality. We, therefore, conclude that zinc supplementation in children is associated with a reduction in diarrhea mortality of 13% and pneumonia mortality of 15% for inclusion in the LiST tool. Preventive zinc supplementation had no effect on malaria specific mortality (RR = 0.90; 95% CI: 0.77, 1.06) or incidence of malaria (RR = 0.92; 95 % CI 0.82-1.04). CONCLUSION: Zinc supplementation results in reductions in diarrhea and pneumonia mortality.

Project description:BACKGROUND:Variable and poor care quality are important causes of preventable patient harm. Many patients receive less than recommended care, but the extent of the problem remains largely unknown. The CareTrack Kids (CTK) research programme sought to address this evidence gap by developing a set of indicators to measure the quality of care for common paediatric conditions. In this study, we focus on one clinical area, 'preventive care' for pre-school aged children. Our objectives were two-fold: (i) develop and validate preventive care quality indicators and (ii) apply them in general medical practice to measure adherence. METHODS:Clinical experts (n = 6) developed indicator questions (IQs) from clinical practice guideline (CPG) recommendations using a multi-stage modified Delphi process, which were pilot tested in general practice. The medical records of Australian children (n = 976) from general practices (n = 80) in Queensland, New South Wales and South Australia identified as having a consultation for one of 17 CTK conditions of interest were retrospectively reviewed by trained paediatric nurses. Statistical analyses were performed to estimate percentage compliance and its 95% confidence intervals. RESULTS:IQs (n = 43) and eight care 'bundles' were developed and validated. Care was delivered in line with the IQs in 43.3% of eligible healthcare encounters (95% CI 30.5-56.7). The bundles of care with the highest compliance were 'immunisation' (80.1%, 95% CI 65.7-90.4), 'anthropometric measurements' (52.7%, 95% CI 35.6-69.4) and 'nutrition assessments' (38.5%, 95% CI 24.3-54.3), and lowest for 'visual assessment' (17.9%, 95% CI 8.2-31.9), 'musculoskeletal examinations' (24.4%, 95% CI 13.1-39.1) and 'cardiovascular examinations' (30.9%, 95% CI 12.3-55.5). CONCLUSIONS:This study is the first known attempt to develop specific preventive care quality indicators and measure their delivery to Australian children in general practice. Our findings that preventive care is not reliably delivered to all Australian children and that there is substantial variation in adherence with the IQs provide a starting point for clinicians, researchers and policy makers when considering how the gap between recommended and actual care may be narrowed. The findings may also help inform the development of specific improvement interventions, incentives and national standards.

Project description:ObjectiveZinc deficiency is widespread, and preventive supplementation may have benefits in young children. Effects for children over 5 years of age, and effects when coadministered with other micronutrients are uncertain. These are obstacles to scale-up. This review seeks to determine if preventive supplementation reduces mortality and morbidity for children aged 6 months to 12 years.DesignSystematic review conducted with the Cochrane Developmental, Psychosocial and Learning Problems Group. Two reviewers independently assessed studies. Meta-analyses were performed for mortality, illness and side effects.Data sourcesWe searched multiple databases, including CENTRAL and MEDLINE in January 2013. Authors were contacted for missing information.Eligibility criteria for selecting studiesRandomised trials of preventive zinc supplementation. Hospitalised children and children with chronic diseases were excluded.Results80 randomised trials with 205 401 participants were included. There was a small but non-significant effect on all-cause mortality (risk ratio (RR) 0.95 (95% CI 0.86 to 1.05)). Supplementation may reduce incidence of all-cause diarrhoea (RR 0.87 (0.85 to 0.89)), but there was evidence of reporting bias. There was no evidence of an effect of incidence or prevalence of respiratory infections or malaria. There was moderate quality evidence of a very small effect on linear growth (standardised mean difference 0.09 (0.06 to 0.13)) and an increase in vomiting (RR 1.29 (1.14 to 1.46)). There was no evidence of an effect on iron status. Comparing zinc with and without iron cosupplementation and direct comparisons of zinc plus iron versus zinc administered alone favoured cointervention for some outcomes and zinc alone for other outcomes. Effects may be larger for children over 1 year of age, but most differences were not significant.ConclusionsBenefits of preventive zinc supplementation may outweigh any potentially adverse effects in areas where risk of zinc deficiency is high. Further research should determine optimal intervention characteristics and delivery strategies.

Dataset Information

Effect of preventive supplementation with zinc and other micronutrients on non-malarial morbidity in Tanzanian pre-school children: a randomized trial.

Background

Methods and findings

Conclusions

Trial registration

Publications

Effect of preventive supplementation with zinc and other micronutrients on non-malarial morbidity in Tanzanian pre-school children: a randomized trial.

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