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）：在印度，胎儿生长不良以及母婴不良出生结局的发生率相当高，多项证据表明母亲的营养状况可能是一个重要因素。我们之前曾对其他环境中胎儿和婴儿的不良结局进行过广泛评估，发现 HIV 阳性坦桑尼亚母亲补充微量营养素（B 族维生素，包括维生素 B12，加上维生素 C 和 E）可降低低出生体重（<2500 g）的风险) 降低 44% (RR (95% Cl) 0.56 (0.38-0.82))，严重早产（妊娠 <34 周）降低 39% (RR 0.61 (0.38-0.96))，出生时胎龄小 43% (RR 0.57 (0.39-0.82))。在一项针对 410 名印度孕妇的前瞻性队列研究中，我们最近发现母体血清维生素 B12 浓度与婴儿宫内生长迟缓 (IUGR) 风险之间存在密切关系。在控制母亲年龄、体重、教育程度和胎次后，与血清 B12 浓度最高三分位的女性相比，最低三分位的女性生出 IUGR 婴儿的可能性明显更高 (OR (95% Cl) 5.98 (1.72-20.74) ））。我们现在提议在 300 名印度孕妇中进行一项随机、双盲试验，以确定补充维生素 B12（每天 50 微克）对于改善孕妇 B12 状况的有效性。这项探索性试验的次要目标包括母亲血红蛋白、母亲怀孕期间的体重增加和婴儿出生体重。所有女性都将接受标准的产前产科护理，包括常规补充铁和叶酸。该研究将由印度班加罗尔圣约翰研究所营养部和美国波士顿哈佛大学公共卫生学院营养系合作完成。正如我们在其他地方成功进行的那样，这项计划研究的结果将用于设计和开展更大规模、更明确的临床试验。作为营养、儿科、流行病学和妇幼健康领域的专家，我们的团队致力于进一步评估微量营养素在改善印度妇幼健康结果方面的可能作用。