Preconception maternal nutrition: a multi-site randomized controlled trial.
Preconception maternal nutrition: a multi-site randomized controlled trial.
复制标题
DOI：
10.1186/1471-2393-14-111
复制
发表时间：
2014-03-20
影响因子：
3.1
通讯作者：
Preconception Trial Group
中科院分区：
文献类型：
--
作者：
Hambidge KM;Krebs NF;Westcott JE;Garces A;Goudar SS;Kodkany BS;Pasha O;Tshefu A;Bose CL;Figueroa L;Goldenberg RL;Derman RJ;Friedman JE;Frank DN;McClure EM;Stolka K;Das A;Koso-Thomas M;Sundberg S;Preconception Trial Group
尽管有证据表明，除了确保围受孕期和整个妊娠前三个月的最佳营养环境外，优化妊娠前母体营养的研究仍然非常有限。这是一项关于母体营养干预开始时间对出生时长（主要结局）影响的个体随机对照试验：第1组：≥ 3个月孕前vs.第2组：12-14周妊娠vs.第3组：无。在四个研究地点（危地马拉、印度、巴基斯坦、刚果民主共和国）的每组中，随机抽取192名（来自480名）母亲和存活后代。干预措施是每天20克脂质（118千卡）多微量营养素（MMN）补充剂。随机接受这种干预的体重指数（BMI）<20或妊娠期体重增加较低的妇女将额外接受300千卡/天的能量-蛋白质平衡补充剂。研究人员将每两周访问一次家庭，提供干预措施，监测依从性、怀孕状况和发病率;确保产前和分娩护理;促进母乳喂养。主要结果是出生长度。次要结局包括：12和34周时的胎儿长度;低出生体重（LBW）的发生率; 0-6月龄的新生儿/婴儿人体测量;传染病发病率;母体、胎儿、新生儿和婴儿表观遗传学;母体和婴儿营养状况;母体和婴儿微生物组;母乳中的肠道炎症生物标志物和生物活性及营养化合物。主要分析将比较试验组之间的出生年龄别身长Z评分（LAZ）（每个研究中心独立进行，估计效应量：0.35）。其他统计分析将检查次要结局和所有研究中心数据的汇总分析。这项试验的积极结果将支持对所有育龄妇女营养的关注的范式转变。ClinicalTrials.gov NCT01883193.
Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age. ClinicalTrials.gov NCT01883193.
登录
查看更多内容
影响因子：
9.8
作者：
Cox, James;Williams, Sarah;Grove, Kevin;Lane, Robert H.;Aagaard-Tillery, Kjersti M.
通讯作者：
Aagaard-Tillery, Kjersti M.
影响因子：
3.8
作者：
Goudar, Shivaprasad S.;Carlo, Waldemar A.;McClure, Elizabeth M.;Pasha, Omrana;Patel, Archana;Esamai, Fabian;Chomba, Elwyn;Garces, Ana;Althabe, Fernando;Kodkany, Bhalachandra;Sami, Neelofar;Derman, Richard J.;Hibberd, Patricia L.;Liechty, Edward A.;Krebs, Nancy F.;Hambidge, K. Michael;Buekens, Pierre;Moore, Janet;Wallace, Dennis;Jobe, Alan H.;Koso-Thomas, Marion;Wright, Linda L.;Goldenberg, Robert L.
通讯作者：
Goldenberg, Robert L.
影响因子：
2.9
作者：
Bogin, B;Smith, P;Loucky, J
通讯作者：
Loucky, J
影响因子：
120.7
作者：
Mook-Kanamori, Dennis O.;Steegers, Eric A. P.;Jaddoe, Vincent W. V.
通讯作者：
Jaddoe, Vincent W. V.
影响因子：
2.8
作者：
Martorell, Reynaldo;Zongrone, Amanda
通讯作者：
Zongrone, Amanda