NCT01883193

Women First: Preconception Maternal Nutrition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7,374 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 16 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-03-30
• Completion: 2019-03-30
• First posted: 2013-06-21
• Last updated: 2021-07-08

Locations

4 sites across 4 countries: Democratic Republic of the Congo, Guatemala, India, Pakistan