CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7,374 enrolled
Drug / intervention
Comprehensive Maternal Nutrition Interventiondietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01883193
NCT01883193N/ACompleted
CompareCT.gov

Women First: Preconception Maternal Nutrition

University of Colorado, Denver·interventional·Posted Jun 21, 2013·Updated Jul 8, 2021

In Brief

A clinical study evaluating Comprehensive Maternal Nutrition Intervention for Maternal Malnutrition and 4 related conditions. Completed, enrolled 7,374 participants across 4 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMaternal Malnutrition, Growth Failure, Mortality, Morbidity, Stunting
CountriesDemocratic Republic of the Congo, Guatemala, India, Pakistan
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Instituto de Nutricion de Centroamerica y Panama (INCAP), Kinshasa School of Public Health, Jawaharlal Nehru Medical College, Aga Khan University, RTI International

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 21, 2013
Enrollment StartAug 1, 2013
Primary CompletionMar 30, 2017
Study CompletionMar 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.0 years ago

Interventions

Comprehensive Maternal Nutrition Interventiondietary

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.