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Adapting iron dose supplementation in pregnancy for greater effectiveness on mother and child health: protocol of the ECLIPSES randomized clinical trial.
Arija, V, Fargas, F, March, G, Abajo, S, Basora, J, Canals, J, Ribot, B, Aparicio, E, Serrat, N, Hernández-Martínez, C, et al
BMC pregnancy and childbirth. 2014;14:33
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Plain language summary
Currently there is no consensus on the best practice for meeting the differing iron needs of pregnant women during the gestational period. Iron needs during pregnancy are influenced by many factors including initial iron status, genetic alterations and dietary intake, and these individual characteristics should be considered when prescribing an iron supplement. The aim of this protocol is to determine a trial design that assesses the effectiveness of iron supplementation adapted to haemoglobin levels at the start of pregnancy relative to the usually prescribed dose. Women in the first trimester will be divided into two groups based on their initial haemoglobin levels and will be randomised to receive either a low or high dose iron supplement. If this protocol is carried out, outcomes should elucidate the optimal iron supplementation dose required to promote maternal and infant health, based on initial haemoglobin levels. These findings would contribute to developing guidelines for good clinical practice.
Abstract
BACKGROUND Currently, there is no consensus regarding iron supplementation dose that is most beneficial for maternal and offspring health during gestation. Recommended iron supplementation dose does not preempt anemia in around 20% of the pregnancies, nor the risk of hemoconcentration in 15%. This deficit, or excess, of iron prejudices the mother-child wellbeing. Therefore the aims of the study are to determine the highest level of effectiveness of iron supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum for mother-child health. METHODS/DESIGN DESIGN Randomized Clinical Trial (RCT) triple-blindedSetting: 10 Primary Care Centers from Catalunya (Spain)Study subjects: 878 non-anemic pregnant women at early gestation stage, and their subsequent newborns METHODS The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of gestation. Stratum #1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d. Stratum #2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d. MEASUREMENTS In the mother: socio-economic data, clinical history, food item frequency, lifestyle and emotional state, and adherence to iron supplement prescription. Biochemical measurements include: Hb, serum ferritin, C reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children: ultrasound fetal biometry, anthropometric measurements, and temperament development.Statistical analyses, using the SPSS program for Windows, will include bivariate and multivariate analyses adjusted for variables associated with the relationship under study. DISCUSSION Should conclusive outcomes be reached, the study would indicate the optimal iron supplementation dose required to promote maternal and infant health. These results would contribute towards developing guidelines for good clinical practice.
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[Abnormal effect of nitrosation inhibitors in human gastric juice].
Ermilov, VB, Shendrikova, IA, Volkov, DP, Stefanenko, IuF, Chernomordikov, VG
Voprosy onkologii. 1986;32(10):58-64
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Plain language summary
Growth faltering in infancy establishes a trajectory for lifelong health of the individual and population. Stunted growth is due to the combined effect inadequate diet (malnutrition) and infection that affects the gut mucosal lining, with increased nutrient loss due to maldigestion and malabsorption, and increased nutritional requirements due to inflammation. Intestinal integrity in infants has been improved through supplementation with vitamin A and Zinc. Iron deficiency anemia may impair intestinal integrity. This study investigates the effects of complementary fortified food on gut integrity and systemic inflammation among Zambian infants age 6-18months. Infants of 6 months +/- 2 weeks old were randomised to either 50g/day richly fortified porridge mix or 50g basal porridge mix fortified with micronutrient levels planned for maize fortification in Zambia. At 18 months, the richly fortified porridge group had a significantly higher mean lactulose to mannitol ratio than the basal-fortified group, indicating they had significantly higher intestinal permeability. This effect was not modified by child’s sex, maternal HIV status, concurrent breast-feeding or baseline anaemia. The biological significance of this increase in intestinal permeability is questionable, however further research is warranted to understand the effect of iron supplementation on gut permeability in infants with normal iron status. In conclusion, a richly fortified complementary/replacement food did not benefit and may have worsened intestinal permeability. Further investigation into local interactions of key micronutrients with gut integrity, particularly in micronutrient-replete infants is needed.
Abstract
The paper discusses the effect of vitamins C and E and Plantaglucide on nitroso compounds yield in the course of nitrosation of amines in human gastric juice. The study group included 56 subjects. The above drugs capable of inhibiting in vitro nitrosation produced an anomalous effect in gastric juice of some subjects, i.e. potentiated nitroso compounds yield in nitrosation of amines by sodium nitrite. The said action of vitamins C and E was apparent in dimethylamine and amidopyrine nitrosation but it was not in morpholine nitrosation. Sharply increased levels in nitroso compounds were observed in some mice fed precursors of nitroso compounds in combination with vitamin C and Plantaglucide. These data point to an anomalous effect of the drugs on the body.