Women First: Preconception Maternal Nutrition

Summary

Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.

Conditions

• Maternal Malnutrition
• Growth Failure
• Mortality
• Morbidity
• Stunting

Interventions

DIETARY_SUPPLEMENT

Comprehensive Maternal Nutrition Intervention

The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Instituto de Nutricion de Centroamerica y Panama (INCAP)

  collaborator UNKNOWN

• Kinshasa School of Public Health

  collaborator OTHER

• Jawaharlal Nehru Medical College

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• RTI International

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Nancy Krebs, MD,MS · University of Colorado, Denver

• Michael Hambidge, MD, SciD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2017-03-30

Completion

2019-03-30

Countries

• Democratic Republic of the Congo
• Guatemala
• India
• Pakistan

Study Locations