Effectiveness of Zinc Supplementation to Full Term Normal Infants: A Community Based Double Blind, Randomized, Controlled, Clinical Trial

<div><p></p><p>The study was aimed to test whether zinc supplementation, if initiated early, can prevent stunting and promote optimum body composition in full term infants. For this, full term pregnant women from low income urban community were enrolled and were followed-up for 24 months postpartum. Body mass index (BMI) was calculated from maternal weight and height that were collected one month after delivery. Infants' weight, and length, head, chest and mid upper arm circumferences and skin fold thicknesses at triceps, biceps and subscapular area were collected at baseline (before randomization) and once in three months up till 24 months. Three hundred and twenty four infants were randomized and allocated to zinc (163) or placebo (161) groups respectively. Supplementation of zinc was initiated from 4 months of age and continued till children attained 18 months. The control (placebo) group of children received riboflavin 0.5 mg/day, whereas the intervention (zinc) group received 5 mg zinc plus riboflavin 0.5 mg/day. When infants were 18 months old, dietary intakes (in 78 children) were calculated by 24 hour diet recall method and hemoglobin, zinc, copper and vitamin A were quantified in blood samples collected from 70 children. The results showed prevalence of undernutrition (body mass index <18.5) in 37% of the mothers. Mean±SD calorie consumption and zinc intakes from diets in infants were 590±282.8 Kcal/day and 0.97±0.608 mg/day respectively. Multiple linear regression models demonstrated maternal weight as a strong predictor of infants' weight and length at 18 months of age. As expected, diarrhea duration impacted infants' linear growth and weight gain adversely. Zinc supplementation for a mean period of 190 days, starting from 4 months up to 18 months of age, in full term normal infants, consuming an average energy of 590 Kcal/day, had significant effect on the skin fold thicknesses, but not on their linear growth.</p><p>Trial Registration</p><p>Clinical Trail Registration India (CTRI) <a href="http://tinyurl.com/k3s8xu7" target="_blank">CTRI/2012/08/002884</a></p></div

Difference in BMDs and hip structural parameters between RUM and RNM with mean and 95% CI in the three models.

<p>¹linear trend</p><p>Crude; non adjusted, Height; adjusted for sex, height, age, and occupation type, All; additionally adjusted for smoking, alcohol consumption, MVPA, lean mass, fat mass and insulin.</p><p>Difference in BMDs and hip structural parameters between RUM and RNM with mean and 95% CI in the three models.</p

Characteristics of matched groups of RNM and RUM (sibs) with mean and SD.

<p>RNM, rural non-migrants; RUM, rural-to-urban migrants</p><p>PA, physical activity; BMI, body mass index</p><p>¹paired sample t-test</p><p>§chi-square test</p><p>*log transformed for statistical tests.</p><p>Characteristics of matched groups of RNM and RUM (sibs) with mean and SD.</p

Difference between RUM and RNM in bone mineral density at lumbar spine (LS), total hip (TH), femoral neck (FN).

<p>Bars represent mean values with 95% CI for different models: crude, height, and fully adjusted.</p

Distribution of socio-demographic and biological characteristics of APCAPS participants (n = 1038), 2009–10.

<p>All values are means(SD) unless otherwise stated.</p><p>MVPA = Moderate or Vigorous Physical Activity; 25(OH)D = 25-hydroxyvitamin D₃, IMT = Intima-Media Thickness, HDL = High-density lipoprotein, LDL = Low-density lipoprotein</p><p>* We used a cut-off of ≤20ng/ml to define deficiency (equal to 50nmol/l) [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0129468#pone.0129468.ref018" target="_blank">18</a>].</p><p>^† p-values are based on unpaired t-tests for heterogeneity in means, with appropriate degrees of freedom.</p><p>^‡ non-normal distribution; median (inter-quartile range) presented, and p-values are based on Mann-Whitney rank-sum tests for equality.</p><p>^Ф Analysis of fasting glucose, insulin, HDL cholesterol and LDL cholesterol exclude participants who did not fast (n = 36)</p><p>^§ Smoking status; former user = ceased use >6 months ago; current user = used in the last 6 months.</p><p>^¶ Manual occupations include roles such as labourers, craftsmen, servants, postal staff and farmers; professional occupations include role such as teachers, accountants, clinicians, business owners and engineers.</p><p>Distribution of socio-demographic and biological characteristics of APCAPS participants (n = 1038), 2009–10.</p

Association of serum vitamin D (25(OH)D)^† with cardiovascular risk factors in a sample of young Indian females from the Andhra Pradesh Children and Parents Study (n = 418)^Ф; 2009–10.

<p>25(OH)D = 25-hydroxyvitamin D3; DXA = Dual X-ray Absorptiometry; BP = Blood Pressure; IMT = Intima-Media Thickness; aPWV = Aortic Pulse Wave Velocity; HDL = High-density lipoprotein; LDL = Low-density lipoprotein</p><p>Model 1 adjusts for age and intervention status. Model 2, as in Model 1, plus further adjustment for lifestyle factors (standard of living index, occupation, time spent in moderate or vigorous physical activity, smoking status), body fat and month of test. Results are based on linear mixed effect regression models with robust standard errors to account for clustering at the household and village level, rounded to 2 decimal places.</p><p>* Model 2 excludes body fat</p><p>^Ф Analysis of fasting glucose, insulin, HDL cholesterol and LDL cholesterol exclude participants who did not fast (n = 36)</p><p>^†Logged values</p><p>Association of serum vitamin D (25(OH)D)^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0129468#t004fn005" target="_blank">†</a>} with cardiovascular risk factors in a sample of young Indian females from the Andhra Pradesh Children and Parents Study (n = 418)^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0129468#t004fn004" target="_blank">Ф</a>}; 2009–10.</p

Key characteristics of APCAPS participants with a serum vitamin D result (n = 1038) compared to APCAPS participants without a serum vitamin D result (n = 408); 2009–10.

<p>Values are means. P-values are based on unpaired t-tests for heterogeneity in means, with appropriate degrees of freedom</p><p>Key characteristics of APCAPS participants with a serum vitamin D result (n = 1038) compared to APCAPS participants without a serum vitamin D result (n = 408); 2009–10.</p