Effectiveness of zinc supplementation to full term normal infants: a community based double blind, randomized, controlled, clinical trial.

UNLABELLED: 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. TRIAL REGISTRATION: Clinical Trail Registration India (CTRI) CTRI/2012/08/002884.

Prevalence of vitamin A deficiency and its determinants among the rural pre-school children of Madhya Pradesh, India.

BACKGROUND: Vitamin A deficiency (VAD) continues to be a major public health nutritional problem in India, even though the National Vitamin A Prophylaxis Programme has been in operation for more than three decades. AIM: To assess the prevalence of vitamin A deficiency among rural pre-school children. SUBJECTS AND METHODS: A community-based cross-sectional study was carried out in rural Madhya Pradesh. A total of 8777 pre-school children were clinically examined for VAD and blood vitamin A levels were estimated in a sub-sample by dried blood spot method. RESULTS: Prevalence of night blindness and Bitot's spot, an objective sign of VAD, was 0.8% and 1.4%, respectively, and prevalence increased significantly (p < 0.001) with age. The proportion of children with blood vitamin A deficiency ( < 20 µg/dL) was 88% (95% CI: 84.8-91.2).The prevalence of Bitot's spot was significantly (p < 0.001) higher among children of lower socio-economic communities, 3-5-year age group and those of illiterate mothers. CONCLUSIONS: VAD is a major public health problem among rural children of Madhya Pradesh. Children of 3-5 years and those belonging to lower socio-economic communities are at high risk of VAD. Therefore, appropriate intervention measures are to be initiated to improve the vitamin A status of children.

Prevalence of anaemia among rural pre-school children of West Bengal, India.

BACKGROUND: Micronutrient malnutrition is a major public health nutritional problem in India, and iron deficiency anaemia (IDA) continues to be a major nutritional problem of public health significance, affecting all physiological groups, of which rural pre-school children are the most vulnerable. AIM: The main aim of the present study was to assess the prevalence of anaemia among rural pre-school children. SUBJECTS AND METHODS: A community-based cross-sectional study was carried out in rural areas of West Bengal State during 2002-2003. A total of 437 pre-school children were covered for the estimation of blood haemoglobin levels. RESULTS: A majority (81%) of the rural children of West Bengal were anaemic, and the prevalence was significantly (p<0.001) higher among 1-3-year-old (91%) as compared to 4-5-year-old (74.6%) children. A significantly (p<0.01) higher proportion of 1+ (OR=7.7; 95% CI: 2.6-22.4) and 2+ year children (OR=3.0; 95% CI: 1.5-6.0) and those belonging to lower socio-economic Scheduled Caste and Scheduled Tribe communities were at risk for anaemia (OR=2.3; 95% CI 1.3-3.9). CONCLUSIONS: The prevalence of anaemia is a severe nutritional problem of public health significance. Therefore, iron supplementation and health and nutrition education programmes should be strengthened. The community needs to be encouraged to diversify their diets by consuming iron-fortified and iron-rich foods.

Clinical and sub-clinical vitamin A deficiency among rural pre-school children of Maharashtra, India.

BACKGROUND: Although a national vitamin A prophylaxis programme has been in operation for more than three decades, vitamin A deficiency (VAD) continues to be a major nutritional problem of public health significance in India. AIM: The present study was carried out with the aim of assessing the prevalence of clinical and sub-clinical VAD among rural pre-school children. SUBJECTS AND METHODS: A community-based cross-sectional study was carried out in rural areas of Maharashtra State during 2002-2003. A total of 8646 pre-school children were examined for the presence of signs and symptoms of VAD. A sub-sample (494) of them was used to estimate blood vitamin A levels. RESULTS: The prevalence of Bitot's spots (1.3%) and night blindness (1.1%) was higher than the WHO cut-off levels used to define a public health problem, and it increased significantly (p<0.001) with increase in age. The prevalence of Bitot's spots was 13 times higher among children belonging to the Scheduled Caste (OR=12.8), and 20 times higher among the children of labourers (OR=19.8). The prevalence of sub-clinical VAD (55%) was significantly (p<0.001) high among the children with night blindness (100%) and Bitot's spots (89%). CONCLUSIONS: Increased vitamin A supplementation, health and nutrition education and consumption of vitamin A rich foods are essential to prevent VAD.

Effect of micronutrient supplementation on health and nutritional status of schoolchildren: growth and morbidity.

OBJECTIVE: We evaluated the effect of a micronutrient-fortified beverage on growth and morbidity in apparently healthy schoolchildren. METHODS: This was a double-blind, placebo-controlled, matched-pair, cluster, randomized study in semi-urban middle-income residential schoolchildren aged 6 to 16 y. Anthropometrics (height and weight), clinical symptoms of deficiency, and morbidity data were collected at baseline in the supplemented group (n = 446 in 10 grades) and the placebo group (n = 423 in 10 grades) and after 14 mo of supplementation (n = 355 in the supplement group and n = 340 in the placebo group from nine pairs). RESULTS: After 14 mo of supplementation, there was a significant increase in mean increments of height and weight z scores of -0.04 and 0.02, respectively, in the supplemented group compared with -0.14 and -0.09 in the placebo group. Velocity of weight (3.56 versus 3.00) was significantly (P < 0.01) higher with supplementation. Although there were no differences in the incidence of common childhood diseases such as fever, cough and cold, diarrhea, and ear infections elicited for a reference period of 1 mo at every quarterly follow-up examination, the mean duration of illness (calculated per person per year) was significantly shorter (5.0 d) in the supplemented group than in the placebo group (7.4 d). CONCLUSIONS: The micronutrient-fortified beverage was beneficial in promoting growth and decreasing duration of common illnesses among middle-class residential schoolchildren who had adequate energy and protein intakes.

Red palm oil supplementation: a feasible diet-based approach to improve the vitamin A status of pregnant women and their infants.

This double-blinded, randomized, controlled study was designed to study the effect of dietary supplementation with red palm oil during pregnancy on maternal and neonatal vitamin A status. A total of 170 women were recruited at 16 to 24 weeks of gestation and randomly assigned to an experimental group that received red palm oil to supply approximately one recommended dietary amount (RDA) (2,400 micrograms) of beta-carotene or to a control group that received an equivalent volume of groundnut oil. The women received the oils for a period of 8 weeks, starting at 26 to 28 weeks of gestation and extending to 34 to 36 weeks of gestation. The mean postintervention (34 to 36 weeks) levels of serum retinol were 1.20 +/- 0.22 (SD) mumol/L (95% CI, 1.15-1.25) in women receiving red palm oil and 0.73 +/- 0.15 mumol/L (95% CI, 0.69-0.77) in their infants; these levels were significantly higher than those in women receiving groundnut oil (1.07 +/- 0.26 mumol/L; 95% CI, 1.01-1.13; p < .01) and their infants (0.62 +/- 0.17 mumol/L; 95% CI, 0.57-0.67; p < .001). A significantly lower proportion of women in the red palm oil group than in the control group had vitamin A deficiency (serum retinol levels < 0.7 mumol/L) after intervention (1.5% vs. 9.7%). The proportion of women having anemia was significantly lower (p < .01) in the red palm oil-supplemented group (80.6%) than in the control group (96.7%). The mean birthweight and gestational age of the infants did not differ significantly between the two groups. An increased risk of low birth-weight (p = .003) and preterm delivery (p = .000) was observed with decreasing serum retinol levels in the third trimester of pregnancy. These results show that red palm oil supplementation significantly improved maternal and neonatal vitamin A status and reduced the prevalence of maternal anemia. Maternal vitamin A status in the later part of pregnancy is significantly associated with fetal growth and maturation. Hence red palm oil, a rich source of bioavailable vitamin A, could be used as a diet-based approach for improving vitamin A status in pregnancy.

Antioxidant defense system and lipid peroxidation in patients with skeletal fluorosis and in fluoride-intoxicated rabbits.

Fluorosis is a serious public health problem in many parts of the world where drinking water contains more than 1 ppm of fluoride. The main manifestations of skeletal fluorosis are crippling bone deformities, spinal compressions, and restricted movements of joints. Although fluorosis is irreversible, it could be prevented by appropriate and timely intervention through understanding the process at biochemical and molecular levels. As in the case of many chronic degenerative diseases, increased production of reactive oxygen species (ROS) and lipid peroxidation has been considered to play an important role, even in the pathogenesis of chronic fluoride toxicity. However, there is inconclusive proof for an altered oxidative stress and antioxidant balance in fluorosis, and the existing data are not only conflicting but also contradictory. In the present communication we have evaluated the antioxidant defense system (both enzymatic and nonenzymatic) and lipid peroxidation in both humans from an endemic fluorosis area (5 ppm fluoride in the drinking water) and in rabbits receiving water with 150 ppm of fluoride for six months. There was no significant difference in lipid peroxidation, glutathione, and vitamin C in the blood of human fluorotic patients and fluoride-intoxicated rabbits as compared to respective controls. Neither were there any changes in the activities of catalase, superoxide dismutase, glutathione peroxidase, or glutathione S-transferase in the blood due to fluoride intoxication (of rabbits) or fluorosis in humans. The results together do not subscribe to oxidative stress theory in fluorosis. Thus, in the absence of clear proof of oxidative damage and to counter toxic effects of fluoride through supplementation of antioxidants, extensive investigations are needed to conclusively prove the role of oxidative stress in skeletal fluorosis.

Serum transferrin receptor in children with respiratory infections.

OBJECTIVE: To study the effect of infection on iron status in children suffering from acute, mild or severe respiratory infections and to determine the nature of anemia in infection using serum transferrin receptor (sTfR) levels. DESIGN: Forty-three children aged between 3 and 5 y with no evidence of infection and receiving iron supplements in the preceding 100 days served as controls. Twenty-one children with mild upper respiratory infection and 94 children hospitalized for acute pneumonia constituted the experimental group. Hemoglobin (Hb), sTfR and serum ferritin were estimated in all the children at the time of diagnosis and again on the 15th and 30th days after the infection in those who were available for follow-up. RESULTS: Mean (95% CI) sTfR was 6.08 (5.1-7.1) mg/l in healthy non-anemic children. Upper respiratory infection had no impact on Hb or sTfR but it significantly elevated serum ferritin levels. Eighty-three percent of the children with pneumonia had Hb less than 110 g/l at the time of diagnosis and had elevated mean sTfR, 18.0 (15.7-20.3) mg/l. There was a decline in mean sTfR by the 15th day of infection to 14.3 (11.3-17.4) mg/l with further rise to 22.9 (13.0-31.9) mg/l by 30 days. Serum ferritin was significantly elevated at the time of diagnosis (85.9; 71.1-100.8 micro g/l) as well as at 15 days (89.1; 68-110.1 micro g/l) with a decline by 30 days. CONCLUSIONS: Severe lower respiratory infection exaggerates iron-deficient erythropoiesis by blocking release of iron from the storage pools. sTfR may not be a sensitive and specific tool of assessing true iron status of children exposed to severe infections.

Safety and impact of vitamin A supplementation delivered with oral polio vaccine as part of the immunization campaign in Orissa, India.

A study was carried out in Orissa, India, to evaluate the impact on vitamin A status of vitamin A supplementation integrated with an immunization campaign. Data were collected from a representative sample of 1,811 children, aged 12 to 48 months, at baseline and then at 4 and 16 weeks following implementation of vitamin A supplementation. The primary outcome indicator was serum retinol. The coverage of vitamin A supplementation was 97%. There was a significant decline in the prevalence of Bitot's spots from 2.9% to 1.9% at 4 weeks, but the prevalence increased to 3.6% by 16 weeks. Serum retinol concentrations increased between baseline and 4 weeks (from 0.62 +/- 0.32 to 0.73 +/- 0.23 mumol/L, p < .001) but then decreased to 0.50 +/- 0.19 mumol/l at 16 weeks, which was significantly lower than at baseline (p < .001). The greatest increase in serum retinol from baseline to 4-week follow-up was among children with lowest baseline serum retinol and children with Bitot's spots at baseline. This study demonstrates the short-term benefits of vitamin A supplementation to be significant, especially for those whose status is most compromised. At the same time, the benefit of vitamin A supplementation in this population was transient. The impact of the vitamin A could not be sustained for the full 16 weeks in the study population. This finding calls for exploration of other means to improve vitamin A status, perhaps by adjusting the vitamin A supplementation schedule with more aggressive measures to improve intake of foods rich in bioavailable vitamin A, such as small amounts of animal foods or fortified foods. The study demonstrates the feasibility of integrating vitamin A supplementation with immunization campaigns.

Effect of dose and formulation on iron tolerance in pregnancy.

BACKGROUND: The National Nutritional Anaemia Prophylaxis Programme (NNAPP) in India was launched in 1971. However, anaemia continues to be a major public health problem. Partial coverage of the population, inadequate dose of the iron supplement, defective absorption due to intestinal infestations and problems with formulation have been recognized as factors responsible for its failure. Therefore, the bioavailability of iron from different formulations containing 60 mg of elemental iron and of tablets with varying doses of elemental iron was undertaken. METHODS: One hundred and fifteen women were randomly allotted to receive different formulations and doses of iron and then undergo iron tolerance tests. They received ferrous sulphate tablets containing 60 mg, 120 mg and 180 mg of elemental iron; formulations containing 60 mg of elemental iron as pure ferrous sulphate salt, ferrous fumarate tablets, ferrous fumarate syrup, excipients added to pure ferrous sulphate salts, powdered ferrous sulphate tablets, iron tablets distributed by the NNAPP and pure ferrous salt in gelatin capsules. RESULTS: The data obtained from 32 subjects were excluded because of non-compliance, intolerance of the medication and lack of results of blood tests. Data from the remaining 83 subjects indicated that increasing the dose of elemental iron from 60 mg to 180 mg improved the bioavailability of iron, but was associated with unacceptable side-effects. Also, liquid formulations of iron had a better bioavailability, with ferrous fumarate syrup and gelatin capsules being the most superior. CONCLUSION: Providing the iron formulation with a high bioavailability should enable the NNAPP to be more successful in decreasing the prevalence of anaemia.

Effect of administration of 200,000 IU of vitamin A to women within 24 hrs after delivery on response to PPV administered to the newborn.

OBJECTIVE: To explore the effect of maternal supplementation of vitamin A on the immune response to oral polio vaccine in breastfed infants. DESIGN: Randomized controlled trial. SETTING: Hospital based. METHODS: One hundred mothers having uncomplicated deliveries randomly received either 200,000 IU vitamin A orally (Experimental) or placebo (Control). All the newborns were given a dose of oral polio vaccine within 72 hours after birth and were breastfed. Type specific neutralizing antibodies to polio viruses in test sera diluted from 1:4 to 1:512 and serum retinol levels were determined from the cord blood and at the age of 6 weeks. Breast milk retinol levels were determined at 3, 10, 30, 45 and 90 days of lactation. RESULTS: Seroconversion to OPV and geometric means of antibody titers to the three types of polio viruses were comparable between the groups of infants belonging to the experimental and control mothers. Breast milk retinol levels were significantly higher in the experimental group upto 45-90 days of lactation. Majority of the infants at birth had serum retinol levels < 15 micrograms/dl which improved significantly by 6 weeks irrespective of the maternal supplementation status. CONCLUSIONS: Maternal vitamin A supplementation soon after delivery improves vitamin A intakes of breastfed infants during the first 3 months and has no interference with the seroconversion to a neonatal dose of OPV. OPV administered to newborn in turn has no adverse effect on the vitamin A status of the breastfed infants.