Preconception maternal nutrition: a multi-site randomized controlled trial

BMC Pregnancy and Childbirth

Shelly Sundberg⁷  Marion Koso-Thomas⁴  Abhik Das⁶  Kristen Stolka⁶  Elizabeth M McClure⁶  Daniel N Frank⁸  Jacob E Friedman⁸  Richard J Derman^1,10  Robert L Goldenberg^1,11  Lester Figueroa⁵  Carl L Bose²  Antoinette Tshefu¹  Omrana Pasha⁹  Balachandra S Kodkany³  Shivaprasad S Goudar³  Ana Garces^1,12  Jamie E Westcott⁸  Nancy F Krebs⁸  K Michael Hambidge⁸ 

[1] Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo (DRC;University of North Carolina, Chapel Hill, NC, USA;KLE University’s Jawaharlal Nehru Medical College, Belgaum, Karnataka, India;Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA;FANCAP, Guatemala City, Guatemala;RTI International, Research Triangle Park, NC, USA;Bill & Melinda Gates Foundation, Seattle, WA, USA;University of Colorado Denver, Aurora, CO, USA;Aga Khan University, Karachi, Pakistan;Christiana Care, Newark, DE, USA;Columbia University, New York, NY, USA;Francisco Marroquin University, Guatemala City, Guatemala

关键词: Microbiome;    Epigenetics;    Birth length;    Nutrition;    Maternal;    Preconception;   

Others  :  1127487
DOI  :  10.1186/1471-2393-14-111

 received in 2014-01-16, accepted in 2014-03-05,  发布年份 2014

【 摘 要 】

Background

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.

Methods/Study design

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.

Discussion

Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age.

Trial registration

ClinicalTrials.gov NCT01883193.

【 授权许可】

   
2014 Hambidge et al.; licensee BioMed Central Ltd.

【 图 表 】

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