Randomized trial of vitamin B12 in pregnant Indian women

印度孕妇维生素 B12 的随机试验

• 批准号: 7231556
• 负责人: CHRISTOPHER P DUGGAN
• 金额: $ 8.89万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7231556
• 关键词: Africa; Anemia; Ascorbic Acid; Asia; Birth; Birth Rate; Boston; Cardiovascular Diseases; Caring; Child; Child Nutrition; Chronic Disease; Clinical Trials; Cognitive; Cohort Studies; Commit; Country; Daily; Developed Countries; Developing Countries; Development; Developmental Disabilities; Diarrhea; Discipline of obstetrics; Double-Blind Method; Education; Effectiveness; Epidemiology; Evaluation; Fetal Growth; Fetal Growth Retardation; Folate; Gestational Age; Growth; HIV Seropositivity; Health; Health Expenditures; Hemoglobin; Homocysteine; Homocystine; Hospitalization; Incidence; India; Infant; Infant Mortality; Infection; Iron; Latin America; Learning; Low Birth Weight Infant; Maternal Age; Maternal and Child Health; Medical; Methylmalonic Acid; Micronutrients; Mothers; Nutritional status; Oral Administration; Outcome; Patient currently pregnant; Perinatal; Placebos; Pneumonia; Pre-Eclampsia; Pregnancy; Premature Birth; Premature Infant; Prematurity of fetus; Prenatal care; Public Health Schools; Randomized; Randomized Controlled Clinical Trials; Rate; Research Institute; Risk; Risk Factors; Role; Serum; Standards of Weights and Measures; Supplementation; Vitamin B 12; Vitamin B Complex; Week; Weight; Weight Gain; Woman; Work; cigarette smoking; design; fetal; improved; infant outcome; literate; maternal serum; nutrition; parity; prenatal; prospective; reproductive; size

DESCRIPTION (provided by applicant): The incidence of poor fetal growth and adverse maternal and infant birth outcomes is quite high in India, and several lines of evidence suggest that maternal nutritional status may be an important factor. We have previously performed extensive evaluations of poor fetal and infant outcomes in other settings, and found that maternal micronutrient supplementation (B vitamins including vitamin B12, plus vitamins C and E) in HIV positive Tanzanian mothers decreased the risk of low birthweight (<2500 g) by 44% (RR (95% Cl) 0.56 (0.38-0.82)), severe preterm birth (<34 weeks of gestation) by 39% (RR 0.61 (0.38-0.96)), and small size for gestational age at birth by 43% (RR 0.57 (0.39-0.82)). In a prospective cohort study of 410 pregnant Indian women, we recently found a strong relationship between maternal serum vitamin B12 concentration and risk of infant intrauterine growth retardation (IUGR). Compared to women in the highest tertile of serum B12 concentration, women in the lowest tertile were significantly more likely to have IUGR infants, after controlling for maternal age, weight, education, and parity (OR (95% Cl) 5.98 (1.72-20.74)). We now propose a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation (50 ug daily) in improving maternal B12 status. Secondary aims for this exploratory trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate. The study will be a collaborative effort between the Division of Nutrition, St John's Research Institute, Bangalore, India, and the Department of Nutrition, Harvard School of Public Health, Boston, US. Findings from this planned study will be used to design and carry out a larger, more definitive clinical trial, as we have successfully performed elsewhere. As experts in the fields of nutrition, pediatrics, epidemiology and maternal and child health, our team is committed to further evaluating the possible role of micronutrients in improving maternal and child health outcomes in India.

描述（由申请人提供）：印度的胎儿生长不良以及不良产妇和婴儿的出生结果的发生率很高，有几条证据表明，孕产妇营养状况可能是一个重要因素。我们先前在其他环境中对胎儿和婴儿不良结局进行了广泛的评估，并发现坦桑尼亚阳性母亲在H​​IV阳性母亲中的孕产妇微量营养素补充（包括维生素B12，以及维生素C和E）的胎儿补充（包括维生素B12，加维生素C和E）可降低低出生体重（<2500 g）的风险44％（<2500 g）（<2500 g）（95％clr 2）（95％cl2）（0.56）（0.56）（0.56）（0.56）（0.56）（0.56）（0.56）。 （妊娠<34周）乘以39％（RR 0.61（0.38-0.96）），出生时胎龄的大小小于43％（RR 0.57（0.39-0.82））。在一项针对410位怀孕印度妇女的前瞻性队列研究中，我们最近发现了母体血清维生素B12浓度与婴儿宫内内生长迟缓（IUGR）之间的牢固关系。与血清B12浓度最高的女性相比，在控制产妇年龄，体重，教育和奇偶校验后，最低三位数的女性更有可能患有IUGR婴儿（OR（95％CL）5.98（1.72-20.74））。现在，我们在300名怀孕的印度妇女中提出了一项随机的双盲试验，以确定补充维生素B12（每天50 UG）在改善母体B12状态方面的有效性。该探索性试验的次要目的包括孕产妇血红蛋白，孕妇在怀孕期间的体重增加和婴儿出生体重。所有妇女将获得产前产科护理的标准，包括用铁和叶酸进行常规补充。这项研究将是印度班加罗尔的St John's Research Institute的营养部与美国波士顿巴斯顿公共卫生学院营养系之间的合作努力。这项计划的研究的发现将用于设计和进行更大，更明确的临床试验，因为我们在其他地方成功执行了。作为营养，儿科，流行病学以及母性和儿童健康领域的专家，我们的团队致力于进一步评估微量营养素在改善印度母婴健康结果中的可能作用。