Catégorie
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2015
Liens
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INTERVENTION: Dietary supplement Group 1 (control ) : 30 women with premature delivery ( < 37 weeks gestation) , without treatment , will not receive vitamin E supplementation after delivery , samples will be collected for 4 days, distributed as follows : the first collection in the first 24 hours after birth , the second 24 hours after the first collection , the third seven days postpartum and Wednesday 30 days after delivery . On the first day blood and breast milk will be collected on other days only breast milk . Group 2 ( treatment) : 30 women with preterm delivery ( < 37 weeks gestation ) who receive supplementation of a capsule of vitamin E in its natural form after delivery , samples will be collected for 4 days, distributed as follows : first collection in the first 24 hours after birth , the second 24 hours after the first collection , the third seven days postpartum and Wednesday 30 days after delivery . On the first day blood and breast milk will be collected on other days only breast milk . J02.500.456 CONDITION: Acquired haemolytic anaemia, Dietary Supplements, nutritional deficiency, Obstetric Labor, Premature ; D59 ; J02.500.456 ; C18.654.521.500 ; C13.703.420.491 C13.703.420.491 C18.654.521.500 J02.500.456 PRIMARY OUTCOME: Expected outcome: Increased alpha‐tocopherol concentration in breast milk in the supplemented group, within 30 days. To increase the verified, we will use the high performance liquid chromatography method compared with a standard. For determining the expected outcome, were taken into account the effect size d = 0.3, alpha 0.05, test the power of 0.8 and a 95% confidence interval. Under these parameters, the minimum sample size required was 38 subjects for each group. Outcome found: Increased alpha‐tocopherol concentration in breast milk in the supplemented group, in the period up to 7 days. The method used to quantify the tocopherol was chromatographed high efficiency, based on comparison to a standard alpha‐tocopherol. The study included 89 women distributed in the control group (n = 51) and supplemented group (n = 38). INCLUSION CRITERIA: Healthy lactating preterm births; single conceptus without malformation; aged 18‐40 years; no history of abortion; without the use of vitamin supplements during pregnancy SECONDARY OUTCOME: Expected outcome: To evaluate the concentration of alpha‐tocopherol colostrum milk, transitional and mature in both groups meets the dietary needs of the newborn. To assess whether the daily intakes for children 0‐6 months of 4 mg / day was treated at different times of lactation was adopted that premature child ingests 254 ± 125 mL / day of milk in the first week of life and 552 mL / day of mature milk, with a month of life. For finding the expected outcomes will be considered the difference between the value established as normal and the value found in each group evaluated before and after supplementation. Outcome Found: Only colostrum milk in the group supplemented reach the nutritional recommendations by AI 4 mg / day of vitamin E for babies 0‐6 months. For assessment of the criteria was adopted that premature child ingests 254 ± 125 mL / day of milk in the first week of life and 552 mL / day of mature milk, with a month of life. Was found in colostrum milk 0h Control Group 3.8 mg / day of alpha‐tocopherol and Group Supplemented 3.4 mg / day. In milk 24h in the control group 3.4 mg / day of alpha‐tocopherol while in the group supplemented 5.8 mg / day. In the transitional milk the concentration of alpha‐tocopherol / day was 2.2 mg / day and 3.4 mg / day for the supplemented group and control group, respectively. In mature milk 2.4 mg / day for the control group and 2.3 mg / day for Supplemented Group.
Epistemonikos ID: 3385823165cfb8ed5a1acb5698fb9f1afc83c418
First added on: Aug 23, 2024