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Zinc supplementation is an effective and feasible strategy to prevent growth retardation in 6 to 24 month children: A pragmatic double blind, randomized trial.

ABSTRACT: Background:Zinc is an essential nutrient that is naturally available in most foods. Deficiency of this micronutrient in particular can cause a number of health complications. Zinc deficiency during infancy is more troublesome as rapid growth and nutrient relied development takes place in this period. Most severe outcomes of zinc deficiency during infancy are considered to be, impaired immunity, growth retardation and impaired neurodevelopment. The aim of this pragmatic study is to determine whether zinc supplementation strategy is feasible and effective for reducing growth retardation at national level. Methods:A randomized, multicenter, double-blind, parallel group effectiveness trial that evaluated the effect of zinc supplementation in infant development. Children aged 6-24 months were recruited from healthcare centers of Damavand, Pishva and Varamin in the beginning of the study (n = 682). The Subjects were then randomly allocated in two groups of intervention (n = 272), and control (n = 308), where a daily dose of zinc sulfate (5ml) suspension containing 5mg elemental zinc and placebo were administered for the period of 6 month. Investigators, care givers and the parents of the children were blinded to the nature of the intervention. Anthropometric measures were evaluated at the beginning and after the six month intervention period. The primary outcome measured was linear growth and length difference, serum zinc and ferritin concentrations were the secondary outcomes. Findings:Following the intervention, compared with the placebo, zinc supplementation was associated with significant difference in the average length increment (primary outcome) (placebo 5·23 ± 2·19 vs. intervention 5·79 ± 2·18 cm, p = 0·02). No significant difference was observed in concentrations of serum zinc and ferritin. After the intervention the prevalence of zinc deficiency was significantly lower in the intervention group compared to the placebo group. No complications and adverse effects were reported and the compliance was very good (7 children out of 344 didn't comply with the intake of syrup). Interpretation:Zinc supplementation for six month among children (6-24 months) had beneficial outcomes on growth and average length increment, therefore we propose it is a feasible strategy for preventing growth retardation.

SUBMITTER: Abdollahi M

PROVIDER: S-EPMC6839004 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Zinc supplementation is an effective and feasible strategy to prevent growth retardation in 6 to 24 month children: A pragmatic double blind, randomized trial.

Abdollahi Morteza M Ajami Marjan M Abdollahi Zahra Z Kalantari Nasser N Houshiarrad Anahita A Fozouni Fereshteh F Fallahrokni Atieh A Mazandarani Foroozan Salehi FS

Heliyon 20191101 11

<h4>Background</h4>Zinc is an essential nutrient that is naturally available in most foods. Deficiency of this micronutrient in particular can cause a number of health complications. Zinc deficiency during infancy is more troublesome as rapid growth and nutrient relied development takes place in this period. Most severe outcomes of zinc deficiency during infancy are considered to be, impaired immunity, growth retardation and impaired neurodevelopment. The aim of this pragmatic study is to determ ...[more]

PMID: 31720482

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Project description:AimsThe burden and health costs of Type 2 Diabetes Mellitus continue to increase globally and prevention strategies in at-risk people need to be explored. Previous work, in both animal models and humans, supports the role of zinc in improving glucose homeostasis. We, therefore, aimed to test the effectiveness of zinc supplementation on glycaemic control in pre-diabetic adults.MethodsWe conducted a randomized, double-blind, placebo-controlled trial across 10 General Practitioner (GP) practices in NSW, Australia. The trial is known as Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD)Study. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4%, 39-46 mmol/mol) men and women (N = 98) were all assigned to a free state government telephone health coaching service (New South Wales Get Healthy Information and Coaching Service) and then randomised to either daily 30 mg zinc gluconate or placebo. Blood tests were collected at baseline, 1, 6 and 12 months for the primary outcomes (HbA1c, fasting blood glucose (FBG)); secondary outcomes included Homeostasis Model Assessment 2 (HOMA 2) parameters, lipids, body weight, height, waist circumference, blood pressure and pulse.ResultsThe baseline-adjusted mean group difference at 6 months, expressed as treatment-placebo, (95% CI) was -0.02 (-0.14, 0.11, p = 0.78) for HbA1c and 0.17 (-0.07, 0.42; p = 0.17) for FBG, neither of which were statistically significant. There were also no significant differences between groups in any of the secondary outcomes. Zinc was well tolerated, and compliance was high (88%).ConclusionWe believe our results are consistent with other Western clinical trial studies and do not support the use of supplemental zinc in populations with a Western diet. There may still be a role for supplemental zinc in the developing world where diets may be zinc deficient.Trial registrationAustralian and New Zealand Clinical Trials Registry, ACTRN12618001120268. Registered on 6 July 2018.

Project description:BackgroundNutrition is an important modifiable risk factor in Alzheimer's disease. Previous trials of the multinutrient Fortasyn Connect showed benefits in mild Alzheimer's disease dementia. LipiDiDiet investigated the effects of Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease. Here, we report the 24-month results of the trial.MethodsLipiDiDiet was a 24-month randomised, controlled, double-blind, parallel-group, multicentre trial (11 sites in Finland, Germany, the Netherlands, and Sweden), with optional 12-month double-blind extensions. The trial enrolled individuals with prodromal Alzheimer's disease, defined according to the International Working Group (IWG)-1 criteria. Participants were randomly assigned (1:1) to active product (125 mL once-a-day drink containing Fortasyn Connect) or control product. Randomisation was computer-generated centrally in blocks of four, stratified by site. All study personnel and participants were masked to treatment assignment. The primary endpoint was change in a neuropsychological test battery (NTB) score. Analysis was by modified intention to treat. Safety analyses included all participants who consumed at least one study product dose. This trial is registered with the Dutch Trial Register, number NTR1705.FindingsBetween April 20, 2009, and July 3, 2013, 311 of 382 participants screened were randomly assigned to the active group (n=153) or control group (n=158). Mean change in NTB primary endpoint was -0·028 (SD 0·453) in the active group and -0·108 (0·528) in the control group; estimated mean treatment difference was 0·098 (95% CI -0·041 to 0·237; p=0·166). The decline in the control group was less than the prestudy estimate of -0·4 during 24 months. 66 (21%) participants dropped out of the study. Serious adverse events occurred in 34 (22%) participants in the active group and 30 (19%) in control group (p=0·487), none of which were regarded as related to the study intervention.InterpretationThe intervention had no significant effect on the NTB primary endpoint over 2 years in prodromal Alzheimer's disease. However, cognitive decline in this population was much lower than expected, rendering the primary endpoint inadequately powered. Group differences on secondary endpoints of disease progression measuring cognition and function and hippocampal atrophy were observed. Further study of nutritional approaches with larger sample sizes, longer duration, or a primary endpoint more sensitive in this pre-dementia population, is needed.FundingEuropean Commission 7th Framework Programme.

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Zinc supplementation is an effective and feasible strategy to prevent growth retardation in 6 to 24 month children: A pragmatic double blind, randomized trial.

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Zinc supplementation is an effective and feasible strategy to prevent growth retardation in 6 to 24 month children: A pragmatic double blind, randomized trial.

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